Venous Thromboembolism Clinical Trial
Official title:
A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)
Verified date | February 2015 |
Source | Daiichi Sankyo, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
Status | Completed |
Enrollment | 92 |
Est. completion date | February 2010 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric) Exclusion Criteria: - Subjects with risks of hemorrhage - Subjects with thrombolic risks - Subjects who weigh less than 40 kg - Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Daiichi Sankyo Co., Ltd. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Incidence of Major or Clinically Relevant Non-major Bleeding | Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints. | 2 weeks | |
Secondary | Proportion of Subjects With Venous Thromboembolism Events. | 2 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05347550 -
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients
|
N/A | |
Enrolling by invitation |
NCT05794165 -
Antithrombin to Improve Thromboprophylaxis and Reduce the Incidence of Trauma-Related Venous Thromboembolism
|
Phase 2 | |
Completed |
NCT02379806 -
The SYMPTOMS - SYstematic Elderly Medical Patients Thromboprophylaxis: Efficacy on Symptomatic OutcoMeS - Study
|
Phase 3 | |
Recruiting |
NCT03691753 -
Safety and Efficacy Study of Fitaya Vena Cava Filter
|
N/A | |
Completed |
NCT02197416 -
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
|
Phase 3 | |
Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
Recruiting |
NCT05171075 -
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
|
Phase 3 | |
Completed |
NCT01895777 -
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
|
Phase 3 | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Completed |
NCT04736719 -
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT04736420 -
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT04735523 -
Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data
|
||
Completed |
NCT02912234 -
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
|
Phase 1 | |
Completed |
NCT02829957 -
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
|
Phase 2/Phase 3 | |
Completed |
NCT02746185 -
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
|
Phase 3 | |
Completed |
NCT02334007 -
Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
|
Phase 1/Phase 2 | |
Completed |
NCT02223260 -
Tolerability , PK/PD and Safety of Dabigatran Etexilate Oral Liquid Formulation in Children < 1 Year of Age
|
Phase 2 | |
Completed |
NCT02661568 -
Description of Patients With Acute Venous Thromboembolism in the UK's Clinical Practice Research Datalink Linked With Hospital Episode Statistics Dataset (CPRD-HES)
|
N/A | |
Completed |
NCT01976988 -
Prospective Study on Preoperative Versus Postoperative Venous Thromboprophylaxis in Patients Undergoing Major Colorectal Surgery
|
Phase 3 | |
Completed |
NCT01431456 -
Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
|
Phase 3 |