An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

Start Date16 May 2019

Sponsor / Collaborator

Aspen Global, Inc.

NL-OMON46006

/ CompletedNot Applicable

A randomized, open-label, crossover study to compare the ratio of pharmacokinetics between Orgaran® and Clexane® in healthy subjects with an historical study. - Orgaran® PK study.

Start Date12 Oct 2017

Sponsor / Collaborator

Aspen Global, Inc.

NCT01304238

/ CompletedNot Applicable

Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht

The purpose of this retrospective registry is to collect data about patients with acute HIT II (Heparin-induced Thrombocytopenia type II) which were treated with Lepirudin, Danaparoid, Argatroban or Fondaparinux. It is a main objective of this registry to mirror the daily routine in this indication in Germany.

Start Date01 Feb 2009

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Danaparoid Sodium

100 Translational Medicine associated with Danaparoid Sodium

100 Patents (Medical) associated with Danaparoid Sodium

1,184

Literatures (Medical) associated with Danaparoid Sodium

01 Mar 2025·Stroke

Impact of Conventional Stroke Risk Factors on Early- and Late-Onset Ischemic Stroke: A Mendelian Randomization Study

Article

Author: Boncoraglio, Giorgio B. ; Gaynor, Brady J. ; Kittner, Steven J. ; Xu, Huichun ; Nguyen, Kevin T.K. ; Perry, James A. ; Cole, John W. ; Adebamowo, Sally N. ; Malik, Rainer ; McArdle, Patrick F. ; Worrall, Bradford B. ; Mitchell, Braxton D. ; O’Connor, Timothy D. ; Zand, Ramin

BACKGROUND:Stroke incidence is decreasing in older ages but increasing in young adults. These divergent trends are at least partially attributable not only to diverging trends in stroke risk factors but may also be due to differences in the impact of stroke risk factors at different ages. To address this latter possibility, we used Mendelian randomization to assess differences in the association of stroke risk factors between early-onset ischemic stroke ([EOS]; onset 18–59 years) and late-onset ischemic stroke ([LOS]; onset ≥60 years).METHODS:We identified genetic variants from the GWAS Catalog for use as instrumental variables to proxy conventional stroke risk factors and then estimated the effects of these variants on risk factors in younger and older individuals in the UK Biobank. We then used these estimates to estimate the causal effects of stroke risk factors on EOS (n=6728 cases) and LOS (n=9272) cases from SiGN (Stroke Genetic Network) and the EOSC (Early-Onset Stroke Consortium). Lastly, we compared odds ratios between EOS and LOS, stratified by TOAST (Trial of ORG 10172 in Acute Stroke Treatment) subtypes, to determine if differences between estimates could be attributed to differences in stroke subtype distributions.RESULTS: EOS was associated with higher levels of body mass index, blood pressure, type 2 diabetes, and lower levels of HDL (high-density lipoprotein) cholesterol (all P ≤0.002), whereas LOS was associated with higher levels of systolic blood pressure ( P =0.0001). The causal effect of body mass index on stroke was significantly stronger for EOS than for LOS (odds ratio, 1.26 versus 1.03; P =0.008). After the subtype-stratified analysis, the difference in causal effect sizes between EOS and LOS for body mass index diminished and was no longer significant. CONCLUSIONS:These results support a causal relationship between body mass index, blood pressure, type 2 diabetes, and HDL cholesterol levels with EOS and blood pressure levels in LOS. Interventions that target these traits may reduce stroke risk.

10 Jan 2025·Clinical Nephrology

Comparison of adverse drug reactions of heparin and its derivates in the European Economic Area based on data from EudraVigilance between 2017 and 2021

Article

Author: Sui, Zhun ; Zuo, Li ; Wang, Yan ; Gan, Liang-ying ; Wang, Mi

INTRODUCTIONHemodialysis patients need long-term frequent use of parenteral anticoagulants, and the side effects need to be taken seriously. This study aimed to assess the reporting of adverse drug reactions (ADRs) following administration of unfractionated heparin (UFH), low molecular weight heparins (LMWHs), fondaparinux, and danaparoid, in relation to their usage in European Economic Area (EEA).MATERIALS AND METHODSThe total number of ADRs of each anticoagulant between 2017 to 2021 was collected using data from the EudraVigilance database. The number of hemorrhages, thrombocytopenia, injection-site reaction, liver injury, hypersensitivity and bone disorder were collected, respectively. Usage of these anticoagulants was estimated using sales data from the IQVIA MIDAS database. The reporting rates of ADRs were calculated and compared using χ²-test.RESULTSBetween 2017 and 2021 in the EEA, the overall ADRs reporting rates per 10,000,000 standard units (SU) of UFH, enoxaparin, nadroparin, dalteparin, fondaparinux, and danaparoid were 12.3, 40.8, 23.6, 36.5, 91.4, and 430.0, respectively. There were significant differences among these drugs (χ² = 7,239.26, p < 0.001). Specifically, hemorrhage and thrombocytopenia were reported at higher rates, ranging from 2.8 to 140.1, and 2.0 to 115.9 per 10,000,000 SU among different anticoagulants. Injection-site reactions and hypersensitivity came in second, between 0.2 - 29.0 and 0.1 - 53.1 per 10,000,000 SU, respectively. The reporting rates for liver injury and bone disorder were reported at low rates.CONCLUSIONThe reporting rates of ADRs for heparin and its derivates were all very low. In comparison, the reporting rate of ADRs for danaparoid and fondaparinux was relatively high. The most commonly reported ADRs were hemorrhage, thrombocytopenia, followed by injection-site reactions and hypersensitivity.

01 Jan 2025·BMJ Open

Importance of infarct topography in determination of stroke mechanism and recurrence risk: a post-hoc analysis of the dabigatran acute treatment of stroke trial

Article

Author: Coutts, Shelagh B ; Buck, Brian H ; Field, Thalia ; Miller, Jodi ; Hill, Michael D ; Cimen, Erol ; Gioia, Laura C ; Butcher, Ken ; Ng, Kelvin ; Benavente, Oscar R ; Sharma, Mukul

ObjectiveTo evaluate the relationship between infarct pattern, inferred stroke mechanism and risk of recurrence in patients with ischaemic stroke. The question is clinically relevant to optimise secondary stroke prevention investigations and treatment.DesignWe conducted a retrospective analysis of the dabigatran treatment of acute stroke II (DATAS II) trial (ClinicalTrials.gove NCTNCT02295826), in which patients underwent diffusion-weighted imaging (DWI) at baseline and 30 days after randomisation to one of two antithrombotic therapies. Patients were classified as embolic, isolated small subcortical infarcts or transient ischaemic attack TIA (no infarct) at baseline and day 30. Stroke mechanism was determined by traditional and modified (based on DWI lesion findings) Trial of Org 10 172 in Acute Stroke Treatment (TOAST) criteria (DWI-TOAST).SettingMulticentre (6) tertiary acute stroke treatment hospitals.Participants305 adults with minor ischaemic stroke (National Institutes of Health Stroke Scale (NIHSS) score≤9).ResultsOf 305 patients, 148 had embolic pattern infarcts, 93 were isolated small subcortical infarcts and 64 had no infarct on baseline MRI (TIA). In the absence of DWI, TOAST classification indicated the mechanism was cryptogenic in 147 patients (48.2%), and small-vessel occlusion in 127 (41.6%). Using, DWI-TOAST, the number of cryptogenic strokes decreased to 123 (40.3%), and the number of small-vessel occlusion strokes increased to 151 (49.5%). Recurrent infarcts were seen in 13% of patients with an MRI-defined embolic infarct pattern and cryptogenic mechanism on DWI-TOAST. The relative risk of recurrent infarction in patients with undetermined aetiology was increased compared with other categories (standardised coefficient=1.0 (0.1, 1.9), p=0.029). The topography of recurrent infarcts was most often embolic (60.9%), but in 39.1% an isolated small subcortical infarct was seen.ConclusionsDefinitive identification of infarct topography with DWI has a significant impact on infarct mechanism classification. The variable relationship between baseline infarct patterns, clinical presentation and recurrent infarct distribution is a challenge to both the lacunar and embolic stroke of uncertain source (ESUS) concepts. Irrespective of aetiological classification, patients with MRI-defined cryptogenic embolic pattern infarcts are at high risk for recurrent events.Trial registration numberLinked to the DATAS II trial. ClinicalTrials.gov IDNCT02295826.

News (Medical) associated with Danaparoid Sodium

08 Dec 2023

·synapse.patsnap.com

What are factor Xa inhibitors and how do you quickly get the latest development progress?

Factor Xa inhibitors are a class of anticoagulant drugs that work by inhibiting Factor Xa, a key enzyme in the coagulation cascade. The development of Factor Xa inhibitors began in the early 1980s, with the first inhibitor, antistasin, being isolated from the salivary glands of the Mexican leech Haementeria officinalis in 1987. Four drugs from this class are currently marketed worldwide. Rivaroxaban (Xarelto) was the first approved Factor Xa inhibitor, becoming commercially available in Europe and Canada in 2008. This was followed by the approval of apixaban (Eliquis) in Europe in 2011 and in the United States in 2012. Edoxaban (Lixiana, Savaysa) was approved in Japan in 2011 and in Europe and the US in 2015. The most recent addition to this class is betrixaban (Bevyxxa), which was approved in the US in 2017¹ Looking ahead, Factor Xa inhibitors are expected to continue to play a significant role in anticoagulant therapy. They are just as efficacious as low molecular weight heparin (LMWH) and warfarin but are given orally and don't need as strict monitoring. However, the emergence of resistance and the lack of an effective reversal drug when bleeding occurs are challenges that need to be addressed. Ongoing research and development efforts are focused on addressing these issues and expanding the clinical applications of Factor Xa inhibitors The analysis of target factor Xa in the pharmaceutical industry reveals a competitive landscape with multiple companies focusing on its development. Pfizer Inc., Bristol Myers Squibb Co., AstraZeneca PLC, Daiichi Sankyo Co., Ltd., and Bayer AG are among the companies growing the fastest under this target. The indications for drugs targeting factor Xa cover a wide range of cardiovascular and thrombotic conditions, indicating their potential in treating these diseases. Small molecule drugs, chemical drugs, and recombinant coagulation factors are progressing rapidly under this target. The European Union, the United States, and Japan are leading in terms of drug development, but China has also shown progress. Further analysis is required to understand the specific progress in China and its impact on the future development of target factor Xa. Overall, target factor Xa presents a promising opportunity in the pharmaceutical industry with a diverse range of companies, indications, drug types, and countries/locations involved in its development. The mechanism of action of factor Xa inhibitorsFactor Xa inhibitors are a type of medication that specifically target and inhibit the activity of factor Xa, which is a key enzyme involved in the blood clotting process. From a biomedical perspective, factor Xa is a crucial component of the coagulation cascade, a series of reactions that leads to the formation of blood clots. By inhibiting factor Xa, these medications prevent the formation of blood clots and reduce the risk of conditions such as deep vein thrombosis, pulmonary embolism, and stroke. Factor Xa inhibitors work by binding to factor Xa and blocking its ability to activate other clotting factors, ultimately preventing the formation of a stable blood clot. This mechanism of action makes them anticoagulant drugs, meaning they help to prevent the excessive formation of blood clots. These inhibitors are commonly used in the treatment and prevention of thromboembolic disorders, such as atrial fibrillation, venous thromboembolism, and post-operative prophylaxis. Examples of factor Xa inhibitors include rivaroxaban, apixaban, and edoxaban. It's important to note that factor Xa inhibitors carry a risk of bleeding, as they interfere with the normal clotting process. Therefore, their use should be carefully monitored, and patients may require regular blood tests to assess their coagulation status. Additionally, factor Xa inhibitors should be used with caution in individuals with certain medical conditions or those taking other medications that increase the risk of bleeding. Catalog of factor Xa InhibitorsThe currently marketed factor Xa inhibitors include: Andexanet alfaHuman Coagulation Factor X(Bio Products)ApixabanEdoxaban TosylateRivaroxabanArdeparin SodiumCertoparin sodiumParnaparin SodiumDanaparoid SodiumDalteparin SodiumFor more information, please click on the image below. What is the purpose of using factor Xa inhibitors?Factor Xa inhibitors that are used to prevent and treat thromboembolic disorders. For more information, please click on the image below to log in and search. How can I get the most recent advancements in factor Xa inhibitors?In the Synapse database, you can keep abreast of the latest research and development advances of factor Xa inhibitors anywhere and anytime, daily or weekly, through the "Set Alert" function. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Danaparoid Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D03644	Danaparoid Sodium	B01AB09	DBSALT001136

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Disseminated Intravascular Coagulation	Japan	neo CritiCare Pharma Co., Ltd.	20 Apr 2001
Venous Thrombosis	Netherlands	Mylan Healthcare BV	07 Jul 1998
Thromboembolism	Netherlands	Organon & Co.	10 Jun 1991
Thrombocytopenia	Netherlands	-	01 Jan 1991
Venous Thromboembolism	Netherlands	-	01 Jan 1991

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Heparin-induced thrombocytopenia	Phase 2	Poland	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	Bosnia and Herzegovina	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	Italy	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	Germany	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	Canada	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	Russia	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	France	Aspen Global, Inc.	16 May 2019
Heparin-induced thrombocytopenia	Phase 2	United States	Aspen Global, Inc.	16 May 2019
Stroke	Phase 1	United States	MSD Oss BV	31 Dec 1995

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