Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
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| ClinicalTrials.gov Identifier: NCT00329628 |
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Recruitment Status :
Completed
First Posted : May 25, 2006
Last Update Posted : October 28, 2014
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Sponsor:
Bayer
Information provided by:
Bayer
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Brief Summary:
The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Venous Thromboembolism | Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4541 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | March 2007 |
| Actual Study Completion Date : | March 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hip Replacement
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1 |
Drug: Rivaroxaban (BAY59-7939)
10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days |
| Active Comparator: Arm 2 |
Drug: Enoxaparin
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days |
Primary Outcome Measures :
- Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes [ Time Frame: Treatment period : up to day 36+/-6 ]
Secondary Outcome Measures :
- Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) [ Time Frame: Treatment period : up to day 36+/-6 ]
- Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period : up to day 36+/-6 ]
- Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period : up to day 36+/-6 ]
- Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 36+/-6 days ]
- The composite endpoint comprising major VTE and treatment-emergent major bleeding [ Time Frame: For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication ]
- Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death [ Time Frame: Treatment period : up to day 36+/-6 ]
- Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death [ Time Frame: Treatment period : up to day 36+/-6 ]
- Treatment-emergent major bleedings [ Time Frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female patients aged 18 years or above
- Patients scheduled for elective total hip replacement
Exclusion Criteria:
- Planned, staged total bilateral hip replacement
- Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
- Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
- Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329628
Locations
Show 215 study locations
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Therapeutic Area Head, Bayer HealthCare AG |
| ClinicalTrials.gov Identifier: | NCT00329628 |
| Other Study ID Numbers: |
11354 EudraCT: 2005-004351-35 |
| First Posted: | May 25, 2006 Key Record Dates |
| Last Update Posted: | October 28, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Bayer:
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Prevention Thromboembolism |
Additional relevant MeSH terms:
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Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Enoxaparin Rivaroxaban Factor Xa Inhibitors |
Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents |