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

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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 subjects with a recent acute coronary syndrome compared with placebo.

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

MedlinePlus related topics: Angina Heart Attack

Drug Information available for: Acetylsalicylic acid Rivaroxaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

The primary outcome measure is the reduction in the risk of the composite endpoint of CV death, MI, or stroke.

Secondary Outcome Measures:

Secondary outcome include assessments of the composite of all cause of death, MI, or stroke, assessments of the composite primary endpoint including severe recurrent ischemia and the net clinical outcome (the composite of efficacy and safety endpoints).

Estimated Enrollment:	16000
Study Start Date:	November 2008

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 subjects 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

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Show 290 Study Locations

Sponsors and Collaborators

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

Bayer

Investigators

Study Director:

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

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

More Information

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR014710
Study First Received:	December 16, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00809965
Health Authority:	United States: Food and Drug Administration

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

Anticoagulation
Myocardial Infarction
Aspirin
Thienopyridine

Acute Coronary Syndrome
ACS
Rivaroxaban
Unstable Angina

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Chest Pain

Signs and Symptoms
Necrosis
Aspirin
Acute Coronary Syndrome
Infarction
Myocardial Infarction
Angina, Unstable

Additional relevant MeSH terms:

Disease
Pathologic Processes
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009