CSP #2037T - Veterans Affairs Learning Health System Initiative to Assess Novel Screening vs. Usual Care and Treatment With Apixaban vs. Rivaroxaban in Veterans With Atrial Fibrillation (VALIANT-AF-T) Trial

* The trial will compare two anticoagulants ("blood thinners") that are currently used in the VA and are considered standard care to prevent strokes in patients with atrial fibrillation. The two most commonly-used anticoagulants will be compared: apixaban (Eliquis) and rivaroxaban (Xarelto). They are considered by many doctors to have similar benefits and risks, but no one knows for sure.
* The trial only enrolls patients with a diagnosis of atrial fibrillation ("A Fib").
* We will measure, in about 10,000 VA patients nationally, whether the rates of stroke, major bleeding, or death differ between these two drugs.
* The trial will last about 7 years, but after the first prescription, all information will be collected from electronic medical records.

Start Date02 Jun 2025

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06933056

/ Not yet recruitingEarly Phase 1IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Start Date01 May 2025

Sponsor / Collaborator

University of Michigan

[+1]

CTIS2024-519660-40-00

/ RecruitingPhase 1

- 02API2024

Start Date06 Apr 2025

Sponsor / Collaborator

Celon Pharma SA

100 Clinical Results associated with Apixaban

100 Translational Medicine associated with Apixaban

100 Patents (Medical) associated with Apixaban

6,994

Literatures (Medical) associated with Apixaban

31 Dec 2025·Journal of Medical Economics

Decision model to evaluate the cost of clinical events associated with switching from apixaban to rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany

Article

Author: Kongnakorn, Thitima ; Duan, Cecilia ; Hines, Dionne M. ; Dworatzek, Elke ; Shah, Anshul ; Kisser, Agnes ; Zhang, Michelle ; Subash, Rupesh ; Hagan, Melissa

AIMSDirect-acting oral anticoagulants (DOACs) have emerged as the preferred treatment for nonvalvular atrial fibrillation (NVAF). However, evidence concerning the economic outcomes of DOAC switching remains limited. This study aimed to assess the economic outcomes of DOAC switching in the US and Germany, two countries with a high AF prevalence and DOAC utilization.METHODSA decision model was developed to assess the incidence and cost of stroke/systemic embolism (SE) and major bleeding (MB) associated with switching from apixaban to rivaroxaban in patients with NVAF. The model compared two scenarios: continuers (patients continuing apixaban) and switchers (patients switching from apixaban to rivaroxaban). Model inputs on clinical event rates were sourced from a published real-world study, cost inputs were from a standard costing database and published literature. The analysis was conducted over a 1-year time horizon from US Medicare fee-for-service and German public healthcare payer perspectives.RESULTSOver one year, 47,036 patients among a hypothetical plan size of 1,000,000 US Medicare fee-for-service members and 1,019,079 patients among the German adult population size of 70,107,122 were estimated to be treated for NVAF with apixaban. Switching all patients from apixaban to rivaroxaban resulted in 1,498 and 32,447 additional clinical events (stroke/SE and MB) and deaths in the US and Germany, respectively, compared to continuing with apixaban. This led to a total incremental cost of $17.3 million and €153 million from Medicare fee-for-service and German public healthcare perspectives, respectively.LIMITATIONSThe incidence and hazard ratios of clinical events informing this analysis were based on a US commercial and Medicare Advantage population and may not be generalizable to other populations.CONCLUSIONSSwitching from apixaban to rivaroxaban was associated with increased clinical events, deaths, and higher medical care costs, potentially representing a less favorable strategy economically compared to continuing apixaban among patients with NVAF.

01 May 2025·Journal of Pharmaceutical and Biomedical Analysis

Simultaneous quantification of eighteen therapeutic oral anticoagulants, rodenticides, and antiplatelet agents by LC-MS/MS and its application in post-mortem forensic cases

Article

Author: Delavenne, Xavier ; Bidat, Carolyne ; Escal, Jean ; Hodin, Sophie ; Duband, Sébastien ; Drague, Angélique ; Dellinger, Sandrine ; Feliu, Catherine

Anticoagulants and antiplatelet agents, which interfere with blood coagulation, can lead to fatal bleeding. Moreover, their widespread use as drugs or rodenticides poses a high risk of accidental or intentional poisoning. Therefore, quantifying these substances is essential in forensic investigations. This research aimed to develop and validate a liquid chromatography-tandem mass spectrometry method capable of quantifying eighteen anticoagulant or antiplatelet compounds (apixaban, rivaroxaban, dabigatran, warfarin, acenocoumarol, fluindione, brodifacoum, bromadiolone, difenacoum, difethialone, chlorophacinone, coumatetralyl, flocoumafen, acetylsalicylic acid, clopidogrel, dipyridamole, ticagrelor, and ticlopidine) in a single run with simple sample preparation. The method was validated according to the FDA recommendations for all compounds, with an eight-min run time in human whole blood, the gold standard in toxicological forensic investigation. The method was also validated for therapeutic compounds and most rodenticides in bile and vitreous humor. Following validation, the method was applied to seven forensic cases with a known history of anticoagulant or antiplatelet agent use to prove the validity of the method. This method provides a valuable tool for legal contexts where precise determination of anticoagulant compound presence and concentration is required.

01 May 2025·Pediatric Drugs

Adverse Events of Factor Xa Inhibitors in Pediatric Patients: A Meta-analysis and Pharmacovigilance Study

Article

Author: Chong, Shan ; Sun, Lan ; Cui, Yimin ; Xiang, Qian ; Hua, Manqi ; Mu, Guangyan

BACKGROUNDThis study aimed to provide a comprehensive review of adverse events (AEs) associated with factor Xa (FXa) inhibitors in pediatric patients.METHODSWe searched PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the European Union Clinical Trials Register for English-language records from the establishment of the database up to October 17, 2023. Both randomized controlled trials and single-arm trials were included. AEs were analyzed using a Bayesian hierarchical model. For the pharmacovigilance study, data from the US Food and Drug Administration Adverse Event Reporting System from January 1, 2007, to December 31, 2023, were obtained. The proportional imbalance method and the Medicines and Healthcare products Regulatory Agency method were used to detect AE signals. Further characterization of patients presenting with AEs was performed.RESULTSOf 451 records identified, 12 eligible studies were included. A total of 50.6% (95% Bayesian credible interval [CrI] 33.1-67.2, τ = 0.796) of patients experienced at least one AE, and 9.9% (95% CrI 3.9-19.5, τ = 0.552) developed at least one serious AE. Major and clinically relevant non-major bleeding occurred in 2.4% (95% CrI 0.8-4.8, τ = 1.61) of patients. The most common bleeding AEs were epistaxis (8.4% [95% CrI 3.9-14.9, τ = 1.96]), subcutaneous hematoma (6.4% [95% CrI 0.5-26.2, τ = 0.54]), and wound hemorrhage (3.7% [95% CrI 0.4-13.3, τ = 0.55]). Non-hemorrhagic AEs were pyrexia (9.2% [95% CrI 4.6-15.3, τ = 1.18]), vomiting (7.8% [95% CrI 4.0-12.3, τ = 0.08]), and abdominal pain (7.4% [95% CrI 1.5-19.4, τ = 0.84]). A total of 39 AE signals were detected in the pharmacovigilance study. The top three highest overall relative odds ratio (ROR) for AEs were observed for haemorrhoidal hemorrhage at 1211.82 (95% CI, 312.69-4696.29), thrombophlebitis at 134.64 (95% CI, 42.18-429.81), and deep vein thrombosis at 68.3 (95% CI, 42.53-109.68). Patients experiencing bleeding AEs had received a mean dosage of rivaroxaban 0.16 mg/kg and apixaban 0.08 mg/kg.CONCLUSIONSSystematically quantified AEs of FXa inhibitors in clinical trials and real-world studies provide an important guide for clinicians. The use of FXa inhibitors in pediatric patients is associated with an acceptable rate of AEs. The most common bleeding AE was epistaxis. Pediatric patients treated with FXa inhibitors were more prone to hemorrhoidal hemorrhage. A safe approach may involve prior use of other anticoagulants followed by careful administration of FXa inhibitors, with a dosing regimen tailored to age and weight. Close monitoring is recommended for peri-procedural anticoagulation and vomiting.

277

News (Medical) associated with Apixaban

01 May 2025

·www.prnewswire.com

CytoSorbents Provides Regulatory Update for DrugSorb-ATR

PRINCETON, N.J., May 1, 2025 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in blood purification therapies for life-threatening conditions in the intensive care unit and cardiac surgery, today provided a regulatory update for DrugSorb™-ATR, its FDA-designated Breakthrough Device. DrugSorb-ATR is designed to reduce the severity of bleeding in patients undergoing coronary artery bypass grafting (CABG) surgery within 2 days of stopping the antiplatelet drug Brilinta® (ticagrelor, AstraZeneca), a commonly used blood thinner. On April 25, 2025, the U.S. Food and Drug Administration (FDA) issued a denial letter regarding the Company's De Novo Request for DrugSorb-ATR, identifying remaining deficiencies that must be addressed before the De Novo Request can be granted, and the device can be authorized for commercialization in the U.S. CytoSorbents has since met with the FDA and will continue to have interactive conversations with the agency to try to resolve the remaining issues. However, if these conversations do not lead to a resolution, a formal appeal will be filed within 60 days. "We remain deeply committed to bringing DrugSorb-ATR to market as an important solution to address the serious, unmet medical need of preventing life-threatening bleeding in CABG patients treated with Brilinta®," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. "With no therapies currently available in the U.S., tens of thousands of patients remain at risk every year. We will continue working closely with FDA and believe we can resolve the remaining issues in a timely manner and still anticipate a final regulatory decision in 2025." About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than 270,000 devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo Request to the U.S. FDA requesting marketing authorization for the DrugSorb-ATR medical device to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR has not been authorized for commercialization in the U.S. or Canada. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. Forward-Looking Statements This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, our restructuring of our direct sales team and strategy in Germany, our ability to resolve remaining deficiencies in the FDA denial letter and/or successfully appeal the FDA's decision, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws. Please Click to Follow Us on Facebook and X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] SOURCE Cytosorbents Corp WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalBreakthrough Therapy

24 Apr 2025

·www.biopharmadive.com

Bristol Myers says schizophrenia drug launch ‘off to a solid start’

A new, closely watched schizophrenia medication from Bristol Myers Squibb sold well in its first full quarter on the market, according to both the company and analysts.In its latest earnings report, Bristol Myers recorded $27 million in net sales from Cobenfy during the three-month period between January and March. Chief Financial Officer David Elkins called that a solid start and said the weekly number of Cobenfy prescriptions remains strong, tracking ahead of all branded specific benchmarks. As of April 11, that number was 1,655.Matt Phipps, an analyst at the investment firm William Blair, echoed those sentiments in a note to clients, describing the results as a nice start. David Risinger, of Leerink Partners, noted that the sales total was 48% above the average analyst estimate.The drugs success is imperative for Bristol Myers, which has watched generic competition erode one of its most lucrative products, the blood cancer treatment Revlimid. Two of its other top-selling medicines,the blood thinner Eliquis and the cancer immunotherapy Opdivo, are also poised to lose patent protection in a few years. Across its whole business, Bristol Myers recorded $11.6 billion in revenue in the first quarter, a 6% decline from the same period last year.Bristol Myers sees Cobenfy as a major product, hence why the company recently shelled out $14 billion to acquire its developer, Karuna Therapeutics. Analysts also have blockbuster expectations, though those were tempered a bit this week when the drug stumbled in testing.Having already secured an approval in schizophrenia, Bristol Myers has been trying to show Cobenfy has a range of other uses. Those include treating bipolar disorder, autism spectrum disorder, symptoms associated with Alzheimers disease, or even being layered onto other antipsychotics for schizophrenia patients.In that last category, however, a nearly 400-person clinical trial just found Cobenfy was not significantly better than a placebo. To some analysts, the setback erases billions of dollars in potential revenue.Perhaps expectedly, Bristol Myers leadership talked down the study failure on a call with investors Thursday. Chief Commercialization Officer Adam Lenkowsky said schizophrenia monotherapy remains the most significant opportunity, accounting for 70% to 80% of the patients treated with Cobenfy.What happens in the real world? Psychiatrists exhaust monotherapy options before trying adjunctiveuse, Lenkowsky said. That's exactly what we've been seeing in the market.Physicians have also told us, both in research and through advisory boards, that missing the endpoint of the study would have no impact on monotherapy usage or their willingness to use Cobenfy, he added.More broadly, Bristol Myers upped its revenue forecast for the year by 2%, to a range of about $45.8 billion to $46.8 billion. The raise was based on operational sales as well as the impact of foreign exchange rates.During the investor call, analysts also pressed the company about its plans to navigate the current political environment, especially Trump administration tariff policies. The U.S. pharmaceutical industry has so far avoided the worst of the tariff impact, but there are strong signs it could get caught in the crosshairs before too long.We have been up investing in core infrastructure in the U.S. for many years. So we need to ensure that, ultimately, our trade policies enhance the sector and support efforts like the ones we've been making, CEO Chris Boerner told investors.In terms of our exposure, again, what we've said is the tariffs that have gone into place, namely around China, have been reflected in the guidance that we provided today, Boerner added.It really is simply too early to provide a lot more on pharma-specific sectors, so we'll have to wait for the specifics there.Bristol Myers shares were about flat as of late Thursday morning, trading a little above $48 apiece. '

AcquisitionImmunotherapy

23 Apr 2025

·www.biopharmadive.com

Bristol Myers’ prized schizophrenia drug stumbles in testing

A brain drug at the center of a recent $14 billion acquisition has failed a large clinical trial, leading some Wall Street analysts to substantially lower their sales forecasts.Bristol Myers Squibb closed a deal to acquire the drug, Cobenfy, and its developer in March of last year, about six months before it was approved in the U.S. as a schizophrenia therapy. While launching Cobenfy, Bristol Myers has simultaneously been working to get the drug cleared for other uses, such as adding it on top of atypical antipsychotics for the treatment of schizophrenia.But that work has now hit a setback. On Tuesday afternoon, Bristol Myers disclosed that an almost 400-person study found its drug not significantly better than a placebo in this setting.All participants in the study were given atypical antipsychotics, with about half taking Cobenfy and the other half a placebo. Using a well-known, 210-point scale that measures the severity of schizophrenia symptoms, researchers found scores in the Cobenfy group improved by 14.3 points. Though that change was roughly two points better than the placebo arm, it wasnt enough to hit the trials main goal.Bristol Myers said it will further analyze the results and discuss them with regulators and the medical community. The company also plans to present more detailed data at an upcoming medical conference.“When patients are already receiving treatment, demonstrating additional statistical benefit becomes inherently more difficult, said Husseini Manji, a professor in Oxford Universitys psychiatry department and co-chair of the U.K. governments Mental Health Goals program, in a statement from Bristol Myers.Although Cobenfy did not demonstrate a statistically significant improvement as an adjunctive treatment in this trial, the data are encouraging, Manji added. These findings warrant additional follow up and may provide valuable direction in our ongoing search for complementary approaches to address these persistent treatment gaps.Analysts view Cobenfy as a vital revenue driver for Bristol Myers, which stands to lose patent protection on two of its most lucrative products the blood thinner Eliquis and the cancer immunotherapy Opdivo in a few years. Yet the trial failure has some rethinking Cobenfys commercial outlook. David Risinger, an analyst at Leerink Partners, previously predicted that Cobenfy revenue would reach $5.8 billion in 2030. Now, he has cut that forecast to $2.6 billion.In a note to clients, Risinger claimed the failure indicates Cobenfy is only modestly effective, igniting fears among his team that the drug has far less potential than we originally anticipated.Sean McCutcheon, from the investment bank Raymond James, lowered his 2030 estimates, too, from a little over $3.7 billion to a little under $3 billion. He also removed the adjuvant schizophrenia opportunity from his model.According to McCutcheon, perhaps the biggest consequence of the study failure is that it might increase the perceived risk of Cobenfy succeeding in the myriad other conditions in which its being tested. Those include bipolar disorder, autism spectrum disorder and symptoms associated with Alzheimer's disease like agitation and psychosis.Others, though, dont appear as worried. William Blair analyst Matt Phipps still sees a significant commercial opportunity for the drug in schizophrenia and, potentially, Alzheimers psychosis. And Carter Gould, of Cantor Fitzgerald, argues the trials outcome isnt as dire as it might seem. Bristol Myers said there were underlying trends favoring Cobenfy, for example.In his own client note, Gould also highlighted how not only was Cobenfy already being used as an adjuvant schizophrenia treatment ahead of the trial results, but feedback given to the Cantor team from some influential doctors suggested they would keep prescribing the drug even if it missed in this setting.Bigger picture, the optics around a negative top-line result for one of the bright spots in the commercial portfolio arent great, but theres likely enough here on efficacy for psychiatrists to justify continued and growing use of the drug in schizophrenia, Gould wrote.Shares of Bristol Myers were down 4%, to about $48 apiece, in pre-market trading on Wednesday. '

AcquisitionImmunotherapyClinical Study

100 Deals associated with Apixaban

External Link

KEGG	Wiki	ATC	Drug Bank
D03213	Apixaban	B01AF02	DB06605

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Embolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Embolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Pulmonary Embolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Stroke	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Stroke	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Stroke	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Stroke	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thromboembolism	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thromboembolism	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thromboembolism	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thromboembolism	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thrombosis	Iceland	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thrombosis	Norway	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thrombosis	European Union	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011
Venous Thrombosis	Liechtenstein	Bristol-Myers Squibb/Pfizer EEIG	18 May 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Embolism	Phase 3	Mexico	Bristol Myers Squibb Co.	01 Nov 2006
Pulmonary Embolism	Phase 3	Canada	Bristol Myers Squibb Co.	01 Nov 2006
Pulmonary Embolism	Phase 3	Brazil	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Mexico	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Canada	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Turkey	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Russia	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Brazil	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Argentina	Bristol Myers Squibb Co.	01 Nov 2006
Venous Thrombosis	Phase 3	Israel	Bristol Myers Squibb Co.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03192215 (ARCADIA, CTgov)	Phase 3	Foramen Ovale, Patent \| Atrial Myxoma, Familial \| Myocardial Infarction \| Mitral Valve Stenosis \| Endocarditis, Bacterial \| Heart Valve Diseases \| Cryptogenic Ischemic Stroke \| Heart Neoplasms \| Heart Diseases	1,015	Apixaban (Active Agent: Apixaban)	zphhurzboz(qfgggbgpau) = ujwijnwuhe qyfcuobxgj (eagngfsgoy, vyrevnfdqb - ddbzrkfrfp) View more	-	09 Apr 2025
				Aspirin (Active Control: Aspirin)	zphhurzboz(qfgggbgpau) = tlsnivbmvk qyfcuobxgj (eagngfsgoy, urpjkzgjlg - wcpwbrkygf) View more
P9-13.008 (AAN2025)	Not Applicable	Atrial Fibrillation systolic blood pressure \| type 2 diabetes \| LDL ... View more	-	Apixaban (Favorable PRFP)	jdirusdssq(yrpismfogm) = dbqwkbztmu plxelnrjpl (epaeuktfaz, 1.00 - 2.20)	Positive	07 Apr 2025
				Apixaban (Adverse PRFP)	-
NCT02415400 (AUGUSTUS, Pubmed \| JACC Adv)	Phase 4	Acute Coronary Syndrome	-	Apixaban 2.5 mg	delxoyziqu(lycealyucc) = ondqiajhdd fbwxwpmevi (ijypiuwdnm )	Positive	01 Apr 2025
				Apixaban 5.0 mg	delxoyziqu(lycealyucc) = qmwtpufigw fbwxwpmevi (ijypiuwdnm )
NCT04650087 (CTgov)	Phase 3	Post Acute COVID 19 Syndrome	1,291	Placebo (Placebo)	phzsznpztc(twiwiksjre) = fahpzkmzme pqokohsoxx (ojegzmpfhg, nrufuigswj - apwwuetzmj) View more	-	25 Feb 2025
				Apixaban 2.5 MG (Apixaban)	phzsznpztc(twiwiksjre) = extaqkvapf pqokohsoxx (ojegzmpfhg, fwsmqlgbzz - rcddtbnldh) View more
NCT06689436 (NEWS) Manual	Phase 2	Thromboembolism	48	TAH3311	(qapajniwra) = 在监管机构认可的范围(80-125%)内 fuvunrecei (sbbdehuppj ) View more	Positive	18 Feb 2025
				艾乐妥
NCT02415400 (AUGUSTUS, Pubmed \| Am Heart J)	Phase 4	Thrombosis \| Acute Coronary Syndrome \| Myocardial Infarction \| Heart Valve Diseases \| Atrial Fibrillation	4,614	Apixaban + Placebo	axbyegkzmf(sdhsanfarv) = txvfgidqqz otsovwoawr (rmbrilyued, 28)	Negative	01 Feb 2025
				Apixaban + Aspirin	axbyegkzmf(sdhsanfarv) = jvyjfqgehy otsovwoawr (rmbrilyued, 29)
ISC2025	Not Applicable	Atrial Fibrillation	-	Apixaban	(vcgugegffd): HR = 0.92 (95% CI, 0.83 - 1.03), P-Value = 0.13 View more	Positive	30 Jan 2025
				Standard of Care (SOC)
All of Us (ISC2025)	Not Applicable	Atrial Fibrillation systolic blood pressure \| type 2 diabetes \| high-density lipoproteins ... View more	-	Apixaban (Favorable Polygenic Profile)	rjvajuvyof(gtzfumuidm) = cumulative incidence:1.5%[95%CI:1.00–2.20] rvuxqyamhj (bfpbbscrwg )	Positive	30 Jan 2025
				Apixaban (Adverse Polygenic Profile)
ARTESIA (ISC2025)	Not Applicable	Atrial Fibrillation	-	Apixaban	pulaxclowd(ofmbuzopun) = bkgrsyghsp ngroiqzmwe (qoiatagcmo, 0.29 - 0.81) View more	Positive	30 Jan 2025
ASH2024	Not Applicable	Obesity, Morbid	-	Apixaban 2.5mg bid	(sokkhgzmwr) = brospxjnax ajlzwmcwam (pnnjkbcymc, ±5.4) View more	-	08 Dec 2024

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