Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00809965
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2008-12-16
Brief Title:
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2014-08
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 determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death myocardial infarction or stroke in patients with a recent acute coronary syndrome compared with placebo
Detailed Description:
Acute coronary syndrome ACS is a serious and life threatening condition Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death myocardial infarction and stroke Six months after patients present with an index event of ST-segment myocardial infarction approximately 15 will either have died or had another episode of myocardial ischemia and a similar situation exists for non-ST-segment elevation myocardial infarctionunstable angina patients This randomized double-blind placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS Patients will be given rivaroxaban 25 mg twice daily or 5 mg twice daily or placebo twice daily in addition to standard care
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 |
|---|---|---|---|
| RIVAROXACS3001 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |