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

Sponsor:	Bayer
Collaborator:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00402597

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: Xarelto (Rivaroxaban, BAY59-7939) Drug: Placebo	Phase II

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)

Resource links provided by NLM:

Drug Information available for: Acetylsalicylic acid Rivaroxaban

U.S. FDA Resources

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 ]

Enrollment:	3487
Study Start Date:	November 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

Detailed Description:

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

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

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11898, EudraCT 2006-004449-40
Study First Received:	November 21, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00402597 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Acute Coronary Syndrome (ACS)

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Pathologic Processes
Aspirin
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases

Analgesics
Heart Diseases
Disease
Cyclooxygenase Inhibitors
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Acute Coronary Syndrome
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010