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

Purpose

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.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Rivaroxaban (BAY59-7939) Drug: Placebo	Phase II

ChemIDplus related topics:

Acetylsalicylic acid Rivaroxaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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)

Further study details as provided by Bayer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	3600
Study Start Date:	November 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) Rivaroxaban twice daily (dose escalation)
Arm 2: Experimental	Drug: Rivaroxaban (BAY59-7939) Rivaroxaban once daily (dose escalation)
Arm 3: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402597

Show 113 Study Locations

Sponsors and Collaborators

Bayer

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

Investigators


Study Director:	Bayer Study Director	Bayer

More Information

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Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11898, EudraCT 2006-004449-40, ATLAS
First Received:	November 21, 2006
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00402597
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Acute Coronary Syndrome (ACS)

Study placed in the following topic categories:

Heart Diseases

Aspirin

Heparin, Low-Molecular-Weight

Myocardial Ischemia

Acute Coronary Syndrome

Vascular Diseases

Ischemia

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Disease

Molecular Mechanisms of Pharmacological Action

Cyclooxygenase Inhibitors

Hematologic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Fibrinolytic Agents

Cardiovascular Agents

Pharmacologic Actions

Fibrin Modulating Agents

Pathologic Processes

Analgesics, Non-Narcotic

Sensory System Agents

Syndrome

Therapeutic Uses

Platelet Aggregation Inhibitors

Cardiovascular Diseases

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Bayer Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00402597