A Multicenter, Randomized, Double-blind, Assessor-blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Biotinylated Idraparinux (SSR126517E) With Oral Adjusted-dose Warfarin in the Prevention of Stroke and Systemic Thromboembolic Events in Patients With Atrial Fibrillation

The objective is to evaluate whether once weekly subcutaneous (SC) injection of idrabiotaparinux sodium (biotinylated idraparinux) is at least as efficient to prevent clots in brain and in the other organs than oral international normalized ratio (INR) adjusted-dose warfarin in patients with atrial fibrillation (AF).

Start Date01 Dec 2007

Sponsor / Collaborator

Sanofi SA

NCT00345618 / CompletedPhase 3

An International, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group, Study of 3-month or 6-month Treatment With SSR126517E (3.0 mg s.c. Once-weekly) Versus Oral INR-adjusted Warfarin in the Treatment of Patients With Symptomatic Pulmonary Embolism With or Without Symptomatic Deep Venous Thrombosis

Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.

Start Date01 Jun 2006

Sponsor / Collaborator

Sanofi SA

NCT00311090 / CompletedPhase 3

International, Multicenter, Randomized, Parallel Group, Double-blind Study, in Patients With Acute Symptomatic Deep Vein Thrombosis of the Lower Limbs, Demonstrating the Bioequipotency at Steady State of Equimolar Doses of SSR126517E (3.0 mg) Once a Week and SR34006 (2.5 mg) Once a Week, Documenting the Safety and Efficacy of Both Compounds During a 6-month Treatment, and Demonstrating the Neutralizing Effect of SSR29261 on the SSR126517E-induced Anti-Xa Activity

The three purposes of this study are the following:
To compare during a 6-month treatment the safety and effectiveness of idrabiotaparinux (SSR126517) with that of idraparinux (SR34006), taking into account new events of deep venous thrombosis (DVT) and pulmonary embolism (PE), and bleeding risk;
To compare the activities of idrabiotaparinux and idraparinux directly in blood during and after a 6-month treatment;
To check the ability of avidin (SSR29261) to reverse the blood thinning activity of idrabiotaparinux at the end of a 6-month treatment period.

Start Date01 Apr 2006

Sponsor / Collaborator

Sanofi SA

100 Clinical Results associated with Idrabiotaparinux sodium

100 Translational Medicine associated with Idrabiotaparinux sodium

100 Patents (Medical) associated with Idrabiotaparinux sodium

Literatures (Medical) associated with Idrabiotaparinux sodium

01 Apr 2020·Journal of Arrhythmia

Clinical outcomes associated with kidney function changes in anticoagulated atrial fibrillation patients: An ancillary analysis from the BOREALIS trial

Article

Author: Shantsila, Alena ; Bai, Ying ; Lip, Gregory Y. H.

AbstractBackgroundPatients with atrial fibrillation (AF) and chronic kidney disease represent a high‐risk group for thromboembolism and bleeding.AimsTo explore the relationship between kidney function changes and outcomes of stroke/systemic embolism (SE), major bleeding and all‐cause death in anticoagulated AF patients participating in the BOREALIS trial comparing efficacy and safety of once‐weekly s.c. idrabiotaparinux to that of warfarin.MethodsChanges in kidney function by estimated glomerular filtration rate (eGFR) were calculated using the Chronic Kidney Disease Epidemiology Collaboration equation in 2765 AF patients. Trial adjudicated outcomes were determined.ResultsAfter a mean follow‐up of 394 days, in 94.4% of the included patients kidney function changed ranging from −30 mL/min to 30 mL/min. The incidence of stroke/SE and major bleeding was similar between patients with deteriorated (reduction in eGFR from baseline over follow‐up) and preserved kidney function change (increase or no change in eGFR from baseline over follow‐up) [stroke/SE: incidence rate (IR): 1.33%/year vs 1.80%/year; hazard ratio (HR) 0.74, 95% confidence interval (CI) 0.41‐1.32, P = .30; major bleeding: IR 1.63%/year vs 1.49%/year, HR 1.10, 95% CI 0.61‐1.97, P = .76]. On Cox regression analysis, patients with deteriorated kidney function were at higher risk for all‐cause death, compared to patients with preserved kidney function (HR: 1.64, 95% CI: 1.02‐2.63, P = .04).ConclusionIn the BOREALIS trial, the risk of adjudicated stroke/SE, major bleedings, and all‐cause death was not related to mild‐moderate follow‐up changes in kidney function (±30 mL/min). The risk of all‐cause death was significantly increased in AF patients with abruptly deteriorating kidney function.

06 Mar 2018·The Cochrane database of systematic reviews

Factor Xa inhibitors versus vitamin K antagonists for preventing cerebral or systemic embolism in patients with atrial fibrillation.

Review

Author: Bruins Slot, Karsten Mh ; Berge, Eivind

BACKGROUNDFactor Xa inhibitors and vitamin K antagonists (VKAs) are now recommended in treatment guidelines for preventing stroke and systemic embolic events in people with atrial fibrillation (AF). This is an update of a Cochrane review previously published in 2013.OBJECTIVESTo assess the effectiveness and safety of treatment with factor Xa inhibitors versus VKAs for preventing cerebral or systemic embolic events in people with AF.SEARCH METHODSWe searched the trials registers of the Cochrane Stroke Group and the Cochrane Heart Group (September 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (August 2017), MEDLINE (1950 to April 2017), and Embase (1980 to April 2017). We also contacted pharmaceutical companies, authors and sponsors of relevant published trials. We used outcome data from marketing authorisation applications of apixaban, edoxaban and rivaroxaban that were submitted to regulatory authorities in Europe and the USA.SELECTION CRITERIAWe included randomised controlled trials (RCTs) that directly compared the effects of long-term treatment (lasting more than four weeks) with factor Xa inhibitors versus VKAs for preventing cerebral and systemic embolism in people with AF.DATA COLLECTION AND ANALYSISThe primary efficacy outcome was the composite endpoint of all strokes and systemic embolic events. Two review authors independently extracted data, and assessed the quality of the trials and the risk of bias. We calculated a weighted estimate of the typical treatment effect across trials using the odds ratio (OR) with 95% confidence interval (CI) by means of a fixed-effect model. In case of moderate or high heterogeneity of treatment effects, we used a random-effects model to compare the overall treatment effects. We also performed a pre-specified sensitivity analysis excluding any open-label studies.MAIN RESULTSWe included data from 67,688 participants randomised into 13 RCTs. The included trials directly compared dose-adjusted warfarin with either apixaban, betrixaban, darexaban, edoxaban, idraparinux, idrabiotaparinux, or rivaroxaban. The majority of the included data (approximately 90%) was from apixaban, edoxaban, and rivaroxaban.The composite primary efficacy endpoint of all strokes (both ischaemic and haemorrhagic) and non-central nervous systemic embolic events was reported in all of the included studies. Treatment with a factor Xa inhibitor significantly decreased the number of strokes and systemic embolic events compared with dose-adjusted warfarin in participants with AF (OR 0.89, 95% CI 0.82 to 0.97; 13 studies; 67,477 participants; high-quality evidence).Treatment with a factor Xa inhibitor significantly reduced the number of major bleedings compared with warfarin (OR 0.78, 95% CI 0.73 to 0.84; 13 studies; 67,396 participants; moderate-quality evidence). There was, however, statistically significant and high heterogeneity (I² = 83%). When we repeated this analysis using a random-effects model, it did not show a statistically significant decrease in the number of major bleedings (OR 0.88, 95% CI 0.66 to 1.17). A pre-specified sensitivity analysis excluding all open-label studies showed that treatment with a factor Xa inhibitor significantly reduced the number of major bleedings compared with warfarin (OR 0.75, 95% CI 0.69 to 0.81), but high heterogeneity was also observed in this analysis (I² = 72%). The same sensitivity analysis using a random-effects model also showed a statistically significant decrease in the number of major bleedings in participants treated with factor Xa inhibitors (OR 0.76, 95% CI 0.60 to 0.96).Treatment with a factor Xa inhibitor significantly reduced the risk of intracranial haemorrhages (ICHs) compared with warfarin (OR 0.50, 95% CI 0.42 to 0.59; 12 studies; 66,259 participants; high-quality evidence). We observed moderate, but statistically significant heterogeneity (I² = 55%). The pre-specified sensitivity analysis excluding open-label studies showed that treatment with a factor Xa inhibitor significantly reduced the number of ICHs compared with warfarin (OR 0.47, 95% CI 0.40 to 0.56), with low, non-statistically significant heterogeneity (I² = 27%).Treatment with a factor Xa inhibitor also significantly reduced the number of all-cause deaths compared with warfarin (OR 0.89, 95% 0.83 to 0.95; 10 studies; 65,624 participants; moderate-quality evidence).AUTHORS' CONCLUSIONSTreatment with factor Xa inhibitors significantly reduced the number of strokes and systemic embolic events compared with warfarin in people with AF. The absolute effect of factor Xa inhibitors compared with warfarin treatment was, however, rather small. Factor Xa inhibitors also reduced the number of ICHs, all-cause deaths and major bleedings compared with warfarin, although the evidence for a reduction in the latter is less robust.

01 Sep 2014·Internal and Emergency MedicineQ3 · MEDICINE

The value of inhibitors of factor Xa for the treatment of pulmonary embolism

Q3 · MEDICINE

Review

Author: Alì Taher ; Raffaele Pesavento ; Sally Temraz ; Paolo Prandoni ; Sofia Barbar

The introduction of factor Xa inhibitors advocated the initiation of clinical trials that addressed the value of anticoagulation in patients with hemodynamically stable primary pulmonary embolism (PE). In the Matisse trial in patients with PE, fondaparinux administered at therapeutic doses followed by vitamin K antagonists (VKA) has shown a comparable efficacy and safety profile to that seen with intravenous adjusted-dose unfractionated heparin/VKA. A long-acting derivative of fondaparinux, idraparinux, failed to achieve similar results. On the other hand, the Cassiopea study revealed that once weekly injections of idrabiotaparinux, a slightly modified form of idraparinux, have similar efficacy and better safety profile compared to VKAs in the long-term treatment of patients with PE. However, the inconvenient parenteral administration of both fondaparinux and idrabiotaparinux limits their routine clinical use. The availability of antithrombotic compounds that can be administered orally in fixed dose, owing to their predictable pharmacokinetics and pharmacodynamics, and have a lower potential for drug and food interactions has opened new horizons for the treatment of patients with PE. The Einstein PE, Amplify and Hokusai studies, conducted with rivaroxaban, apixaban and edoxaban, respectively, showed that for the treatment of PE they possess a more favorable benefit-to-risk profile than the conventional antithrombotic drugs. In addition, rivaroxaban and apixaban make it possible to treat uncomplicated PE patients from the beginning, without the need for the parenteral administration of heparins or fondaparinux, and edoxaban allows the treatment of fragile patients with lower doses. All of them cover a wide spectrum of clinical presentations, including PE patients at intermediate risk.

100 Deals associated with Idrabiotaparinux sodium

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Venous Thrombosis	Phase 3	BR	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	ZA	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	US	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	US	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	ZA	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	DK	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	DK	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 3	AR	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 1	AR	Sanofi SA	01 Apr 2006
Venous Thrombosis	Phase 1	BR	Sanofi SA	01 Apr 2006

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00580216 (Pubmed \| J Thromb Haemost)	Phase 3	Atrial Fibrillation	3,773	Idrabiotaparinux	xvbzljdxrr(joxsyroacb) = qekdjsglte bdgsgtbieg (yraafplhih )	Positive	01 Jun 2014
				Warfarin	xvbzljdxrr(joxsyroacb) = yttbbzazxj bdgsgtbieg (yraafplhih )
NCT00311090 (EQUINOX, Pubmed \| Br J Clin Pharmacol)	Phase 1	Venous Thrombosis	757	idrabiotaparinux	zpazjgjcrb(bigyogaofq): ratio estimate = 0.95 (90% CI, 0.87 - 1.04) View more	-	01 May 2013
				idraparinux
NCT00311090 (Pubmed \| J Thromb Haemost)	Phase 3	Venous Thrombosis	757	Idrabiotaparinux (3 mg)	xfecxyrekc(kpyjncyxoz) = mxnqrwzetl bujkcwozox (iolctmfmwl ) View more	-	01 Jan 2011
				Idraparinux (2.5 mg)	xfecxyrekc(kpyjncyxoz) = yyudtwwlrz bujkcwozox (iolctmfmwl ) View more

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