An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809965
• Other study ID #: CR014710
• Secondary ID: RIVAROXACS3001
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: August 26, 2014
• Start date: November 2008
• Est. completion date: September 2011

Study information

• Verified date: August 2014
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCroatia: Ministry of Health and Social CareGreat Britain: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 infarction/unstable 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 (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15526
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation

• Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding

• Need for continued anticoagulant therapy

• Significant renal impairment or known significant liver disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Syndrome
• Unstable Angina

Intervention

Drug:
• Rivaroxaban 2.5 mg
One tablet twice daily
• Rivaroxaban 5 mg
One tablet twice daily
• Placebo
One placebo tablet twice daily
• Standard of care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Croatia,  Czech Republic,  Denmark,  Egypt,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Morocco,  Netherlands,  New Zealand,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden,  Thailand,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke	The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	No
Secondary	The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	No
Secondary	The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	No
Secondary	The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	No
Secondary	The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	No