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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Collaborator: |
Bayer |
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00403767 |
Purpose
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Stroke Embolism |
Drug: Rivaroxaban Drug: Rivaroxaban placebo Drug: Warfarin Drug: Warfarin placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation |
| Enrollment: | 14269 |
| Study Start Date: | December 2006 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 001
Rivaroxaban placebo Equal number of rivaroxaban placebo tablets up for up to an expected maximum treatment period of 32 months that may extend up to 4 years,Warfarin Number of warfarin tablets to be determined by dose based on target INR values once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years
|
Drug: Rivaroxaban placebo
Equal number of rivaroxaban placebo tablets up for up to an expected maximum treatment period of 32 months that may extend up to 4 years
Drug: Warfarin
Number of warfarin tablets to be determined by dose based on target INR values once daily for up to an expected maximum treatment period of 32 months that may extend up to 4 years
|
|
Experimental: 002
Rivaroxaban One 20 mg tablet once daily (one 15 mg tablet once daily in patients with moderate renal impairment) for up to an expected maximum treatment period of 32 months that may extend up to 4 years,Warfarin placebo 1 warfarin placebo tablet for up to an expected maximum treatment period of 32 months that may extend up to 4 years
|
Drug: Rivaroxaban
One 20 mg tablet, once daily (one 15 mg tablet, once daily, in patients with moderate renal impairment) for up to an expected maximum treatment period of 32 months that may extend up to 4 years
Drug: Warfarin placebo
1 warfarin placebo tablet for up to an expected maximum treatment period of 32 months that may extend up to 4 years
|
Patients with non-valvular atrial fibrillation who are at risk for stroke and non-central nervous system (non-CNS) systemic embolism, will be randomized (assigned by chance) to receive treatment with rivaroxaban or warfarin, two different anticoagulants (substances that prevent blood clots). Treatment will be double-blinded (neither the patient nor study staff will know which study drug is assigned to patients during the study). Patients assigned to rivaroxaban will receive rivaroxaban 20 mg p.o. once daily (OD) plus warfarin placebo p.o. OD titrated to a target sham international normalized ratio (INR) of 2.5. Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg p.o. OD. Patients assigned to warfarin will receive warfarin p.o. OD titrated to a target INR of 2.5 plus rivaroxaban placebo p.o. OD. The maximum expected length of treatment is up to 32 months but may be extended up to 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Responsible Party: | VP Franchise Medical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00403767 History of Changes |
| Other Study ID Numbers: | CR012157, 39039039AFL3001, ROCKET AF |
| Study First Received: | November 23, 2006 |
| Last Updated: | July 11, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Non-central nervous system systemic embolism Non-valvular atrial fibrillation Blood Clot Rivaroxaban |
Warfarin Anticoagulants Arrhythmias, Cardiac |
|
Atrial Fibrillation Embolism Stroke Cerebral Infarction Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Embolism and Thrombosis Vascular Diseases Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Brain Infarction Brain Ischemia Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
