Clinical trials: Anticoagulants
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma
Healthy
Bioequivalence Study of a Generic Enoxaparin Sodium to Clexane® After Single Subcutaneous Dose in Healthy Human Subjects
This is a single-dose, randomized, double-blind, two-period, two-treatment, two-sequence, crossover, balanced, pharmacodynamic (PD) study with 7 days wash-out period.
- Trial name
- NCT05265676
- Testing
- Enoxaparin Sodium (Venus Remedies Limited), Enoxaparin Sodium (Sanofi)
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Venus Remedies Limited
Acute Coronary Syndrome, Venous Thrombosis
Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice (Sweden)
This prospective cohort study will provide information about: Characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed standard of care for the first…
- Conditions
- Acute Coronary Syndrome, Venous Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Trial name
- NCT02468102
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of care drugs
- Where
- Sweden
- Volunteers
- 99,999 people
- Sponsor
- Bayer
Lymphoma, Acute Lymphoblastic Leukemia
A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma.
- Trial name
- NCT02369653
- Testing
- Apixaban, No systemic anticoagulant prophylaxis
- Where
- 96 sites in United States, Australia and 10 more
- Volunteers
- 512 people
- Sponsor
- Bristol-Myers Squibb
Cardiac Disease
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment.
- Trial name
- NCT03395639
- Testing
- Edoxaban, Standard of Care (SOC)
- Where
- 48 sites in United States, Austria and 12 more
- Volunteers
- 168 people
- Sponsor
- Daiichi Sankyo
Venous Thromboembolism
Safety and Pharmacokinetics Study of DU-176b Administered to Patients With Severe Renal Impairment Undergoing Orthopedic Surgery of The Lower Limbs
To assess the safety and pharmacokinetics of DU-176b administered to patients with severe renal impairment undergoing orthopedic surgery of the lower limbs, compared with DU-176b administered to patients with mild renal…
- Trial name
- NCT01857583
- Testing
- 15mg DU-176b, 30mg DU-176b, Fondaparinux
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Healthy
A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
The primary purpose of this study is to evaluate the reversal of the anticoagulant effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa (rFVIIa) in healthy participants as…
- Trial name
- NCT04543383
- Testing
- Milvexian, 4-Factor Prothrombin Complex Concentrate (4F-PCC), Recombinant Human Factor VIIa (rFVIIa)
- Where
- Netherlands
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Venous Thromboembolism
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total hip replacement surgery.
- Trial name
- NCT00913120
- Testing
- YM150, Enoxaparin
- Where
- 16 sites in Japan, South Korea and 2 more
- Volunteers
- 610 people
- Sponsor
- Astellas Pharma Inc
Healthy
Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
The study will assess the distribution and variability of whole blood clotting time (WBCT) measurement in human blood collected from healthy volunteers that is untreated and spiked with predetermined concentrations of edoxaban or…
- Trial name
- NCT03296982
- Testing
- Blood drawn by direct venipuncture, edoxaban, Enoxaparin
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Venous Thromboembolism, Deep Venous Thrombosis
A Study Comparing Abelacimab to Apixaban in the Treatment of Cancer-associated VTE
This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism
- Trial name
- ASTER (NCT05171049)
- Testing
- Abelacimab, Apixaban
- Where
- 209 sites in United States, Australia and 19 more
- Volunteers
- 1,150 people
- Sponsor
- Anthos Therapeutics, Inc.
Anticoagulant Reversal
Clinical Trial Assessing Non-Inferiority of Freeze Dried Plasma to Fresh Frozen Plasma in Reversing Warfarin
The purpose of this research study is to see how well an experimental freeze dried plasma product, known as FDP, works to reverse the anticoagulation effects of a prescription medication called warfarin sodium (warfarin) compared…
- Trial name
- NCT04794348
- Testing
- Fresh Frozen Plasma (FFP), Freeze Dried Plasma (FDP)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Teleflex
Hemorrhage
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in…
- Trial name
- NCT03343704
- Testing
- Idarucizumab
- Where
- 13 sites in China
- Volunteers
- 19 people
- Sponsor
- Boehringer Ingelheim
Anticoagulant
A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344
A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344
- Trial name
- NCT04673695
- Testing
- Lixiana(D006), CKD-344
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Bleeding
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute…
- Trial name
- NCT02329327
- Testing
- Andexanet
- Where
- 87 sites in United States, Belgium and 7 more
- Volunteers
- 479 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Thrombosis
Vitamin K2 Intervention in Patients With Vitamin K Antagonists
The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy…
- Trial name
- SAFEK (NCT01533441)
- Testing
- Vitamin K2
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Danisco
Arthroplasty, Replacement, Hip, Thrombosis
Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the…
- Trial name
- NCT00107900
- Testing
- DU-176b
- Where
- United States
- Volunteers
- 606 people
- Sponsor
- Daiichi Sankyo
Atrial Fibrillation
Sequential Expansion of Comparative Effectiveness of Anticoagulants
This cohort study is the sequential expansion of the comparative effectiveness study of oral anticoagulants and plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database…
- Trial name
- NCT02081807
- Where
- United States
- Volunteers
- 221,228 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
- Trial name
- NCT01181102
- Testing
- edoxaban, enoxaparin sodium
- Where
- 3 sites in Japan, Taiwan
- Volunteers
- 716 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Venous Thromboembolism
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.
- Trial name
- NCT00917254
- Testing
- YM150, Enoxaparin
- Where
- 13 sites in Japan, Taiwan and 1 more
- Volunteers
- 369 people
- Sponsor
- Astellas Pharma Inc
Whole Blood Donation and Leukoreduction
Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial
The primary goal of Hemanext. is to improve red cell storage through novel storage methods. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during…
- Trial name
- NCT03301779
- Testing
- Hemanext Red Blood Cell Processing System
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hemanext