Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial) - Tabular View

Tracking Information

First Received Date ^ICMJE

November 21, 2006

Last Updated Date

July 7, 2009

Start Date ^ICMJE

November 2006

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety of rivaroxaban in subjects with recent ACS (including STEMI, NSTEMI, or UA) who are treated with aspirin alone or aspirin plus a thienopyridine [ Time Frame: 6 months plus 30 days follow up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Safety of rivaroxaban in subjects with recent ACS (including STEMI, NSTEMI, or UA) who are treated with aspirin alone or aspirin plus a thienopyridine

Change History

Complete list of historical versions of study NCT00402597 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Benefit risk assessment [ Time Frame: 6 months plus 30 days follow up ] [ Designated as safety issue: No ]
Overall safety of rivaroxaban treatment [ Time Frame: 6 months plus 30 days follow up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Benefit risk assessment
Overall safety of rivaroxaban treatment

Descriptive Information

Brief Title ^ICMJE

Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)

Official Title ^ICMJE

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. The ATLAS ACS TIMI 46 Trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Aspirin With or Without Thienopyridine Therapy in Subjects With Acute Coronary Syndrome)

Brief Summary

The purpose of this study is to evaluate the safety of rivaroxaban in subjects with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the rate of important clinical events in those patients.

Detailed Description

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Coronary Syndrome

Intervention ^ICMJE

Drug: Xarelto (Rivaroxaban, BAY59-7939)
Rivaroxaban twice daily (dose escalation)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Rivaroxaban once daily (dose escalation)
Drug: Placebo
Placebo

Study Arms / Comparison Groups

Arm 1: Experimental
Intervention: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 2: Experimental
Intervention: Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 3: Placebo Comparator
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3487

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male and female patients aged 18-75 years
Have symptoms suggestive of ACS and a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina with at least 1 high risk feature

Exclusion Criteria:

Active bleeding or high risk of bleeding or intracranial hemorrhage
Need for continued anticoagulant therapy
Significantly impaired renal or hepatic function
Severe concomitant diseases such as cardiogenic shock, refractory ventricular arrhythmias, or any severe condition that would limit life expectancy to less than 6 months

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil, South Africa, Spain, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00402597

Responsible Party

Therapeutic Area Head, Bayer HealthCare AG

Study ID Numbers ^ICMJE

11898, EudraCT 2006-004449-40

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP