Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement. (RECORD 3)
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| ClinicalTrials.gov Identifier: NCT00361894 |
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Recruitment Status :
Completed
First Posted : August 9, 2006
Last Update Posted : October 27, 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 prevents blood clot which may form after a knee 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 : | 2531 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement. |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | January 2007 |
| Actual Study Completion Date : | January 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Knee Replacement
Drug Information available for:
Rivaroxaban
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1 |
Drug: Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days |
| Active Comparator: Arm 2 |
Drug: Enoxaparin
Syringe of enoxaparin at a dose of 40 mg 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 13+/-4 ]
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 13+/-4 ]
- Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period: up to Day 13+/-4 ]
- Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period: up to Day 13+/-4 ]
- Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 13+/-4 days ]
- The composite endpoint comprising major VTE and treatment-emergent major bleeding [ Time Frame: For major VTE, treatment period: up to Day 13+/-4 ; 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 13+/-4 ]
- 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 13+/-4 ]
- 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 knee replacement Exclusion Criteria:- Active bleeding or high risk of bleeding contraindicating treatment with LMWH- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)- Conditions prohibiting bilateral venography (e.g. amputation of 1 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): NCT00361894
Locations
Show 143 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 Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00361894 |
| Other Study ID Numbers: |
11356 EudraCT: 2005-004620-40 |
| First Posted: | August 9, 2006 Key Record Dates |
| Last Update Posted: | October 27, 2014 |
| Last Verified: | October 2014 |
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 |