CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3,490 enrolled
Drug / intervention
Rivaroxaban/Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00402597
NCT00402597Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Nov 22, 2006·Updated Oct 4, 2012

In Brief

A Phase 2 clinical trial evaluating Rivaroxaban/Placebo, Placebo, and 1 other intervention for Acute Coronary Syndrome. Completed, enrolled 3,490 participants.

Detailed Summary

The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
Countries--
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 22, 2006
Enrollment StartNov 1, 2006
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.6 years ago

Interventions

Rivaroxaban/Placebodrug

1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.

Placebodrug

1 placebo tablet twice daily for 6 months.

Rivaroxabandrug

1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.