CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3,037 enrolled
Drug / intervention
Acetylsalicylic acid +3 moredrug
Likely dose
Acetylsalicylic acid 100 mgfrom 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/NCT02293395
NCT02293395Phase 2Completed
CompareCT.gov

A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome

Janssen Research & Development, LLC·interventional·Posted Nov 18, 2014·Updated Dec 26, 2017

In Brief

A Phase 2 clinical trial evaluating Acetylsalicylic acid, Rivaroxaban, and 2 other interventions for Acute Coronary Syndrome. Completed, enrolled 3,037 participants across 259 sites in 20 countries.

Detailed Summary

The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Coronary Syndrome
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Hungary, Japan, Netherlands, Poland, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United States
CollaboratorsBayer, Duke Clinical Research Institute, Harvard Medical School (HMS and HSDM)

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 18, 2014
Enrollment StartApr 20, 2015
Primary CompletionOct 14, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.6 years ago

Interventions

Acetylsalicylic aciddrug

ASA 100 mg enteric-coated tablet once daily orally.

Rivaroxabandrug

Rivaroxaban 2.5 mg tablet twice daily orally.

Clopidogreldrug

Clopidogrel 75 mg once daily orally.

Ticagrelordrug

Ticagrelor 90 mg twice daily orally.