Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement (RECORD 2)
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| ClinicalTrials.gov Identifier: NCT00332020 |
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Recruitment Status :
Completed
First Posted : May 31, 2006
Last Update Posted : January 27, 2015
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Sponsor:
Bayer
Information provided by (Responsible Party):
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 can help prevent blood clots forming after a hip replacement operation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prevention Venous Thromboembolism | Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2457 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | RECORD 2 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 Hip Replacement. |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | May 2007 |
| Actual Study Completion Date : | June 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hip Replacement
Drug Information available for:
Rivaroxaban
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1 |
Drug: Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days |
| Active Comparator: Arm 2 |
Drug: Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 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 35+/-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 35+/-6 ]
- Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period: up to day 35+/-6 ]
- Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period: up to day 35+/-6 ]
- Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 35+/-6 days ]
- The composite endpoint comprising major VTE and treatment-emergent major bleeding [ Time Frame: For major VTE, treatment period: up to Day 35+/-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 35+/-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 35+/-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): NCT00332020
Locations
Show 126 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: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00332020 |
| Other Study ID Numbers: |
11357 2005-004691-20 ( EudraCT Number ) |
| First Posted: | May 31, 2006 Key Record Dates |
| Last Update Posted: | January 27, 2015 |
| Last Verified: | January 2015 |
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 |