An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	Bayer
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00809965

Purpose

The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Condition	Intervention	Phase
Acute Coronary Syndrome Myocardial Infarction Myocardial Ischemia Unstable Angina	Drug: Rivaroxaban 2.5 mg Drug: Rivaroxaban 5 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Attack

Drug Information available for: Rivaroxaban

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

The reduction in the risk of the composite endpoint of CV death, MI, or stroke. [ Time Frame: From the time of randomization up to the completion of the treatment phase. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The composite of all cause death, MI, or stroke [ Time Frame: From the time of randomization up to the completion of the treatment phase. ] [ Designated as safety issue: No ]
The composite primary endpoint including severe recurrent ischemia and the net clinical outcome (the composite of efficacy and safety endpoints) [ Time Frame: From the time of randomization up to the completion of the treatment phase. ] [ Designated as safety issue: No ]

Enrollment:	15527
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 Rivaroxaban 2.5 mg One 2.5 mg rivaroxaban tablet twice daily for up to 6 months	Drug: Rivaroxaban 2.5 mg One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Experimental: 002 Rivaroxaban 5 mg One 5 mg rivaroxaban tablet twice daily for up to 6 months	Drug: Rivaroxaban 5 mg One 5 mg rivaroxaban tablet twice daily for up to 6 months
Placebo Comparator: 003 Placebo One placebo tablet twice daily for up to 6 months	Drug: Placebo One placebo tablet twice daily for up to 6 months

Detailed Description:

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion Criteria:

Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
Need for continued anticoagulant therapy
Significant renal impairment or known significant liver disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809965

Sponsors and Collaborators

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

Bayer

Investigators

Study Director:

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

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

More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2–TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. Epub 2011 Nov 13.

Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6.

Responsible Party:	VP FRANCHISE MED LDR, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00809965 History of Changes
Other Study ID Numbers:	CR014710, RIVAROXACS3001
Study First Received:	December 16, 2008
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Rivaroxaban
Acute Coronary Syndrome
ACS
Aspirin
Thienopyridine

Unstable Angina
Myocardial Infarction
Anticoagulation
Clopidogrel (Plavix)

Additional relevant MeSH terms:

Angina, Unstable
Myocardial Ischemia
Coronary Artery Disease
Infarction
Ischemia
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on February 09, 2012