Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403767
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2006-11-23
Brief Title:
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 orally po once daily OD plus warfarin placebo po OD titrated to a target sham international normalized ratio INR of 25 Patients with moderate renal impairment at screening will receive rivaroxaban 15 mg po OD Patients assigned to warfarin will receive warfarin po OD titrated to a target INR of 25 plus rivaroxaban placebo po OD The maximum expected length of treatment is up to 32 months but may be extended up to 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 39039039AFL3001 | OTHER | None | None |
| ROCKET AF | OTHER | None | None |
| 2006-004595-13 | EUDRACT_NUMBER | Johnson Johnson Pharmaceutical Research and Development LLC | None |