Back to resultsAn Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban 2.5 mg
Rivaroxaban 5 mg
Placebo
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Rivaroxaban, Acute Coronary Syndrome, ACS, Aspirin, Thienopyridine, Unstable Angina, Myocardial Infarction, Anticoagulation, Clopidogrel (Plavix)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Rivaroxaban 2.5 mg bid
Rivaroxaban 5 mg bid
Placebo
Arm Description
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
One 5 mg rivaroxaban tablet twice daily for up to 6 months
One placebo tablet twice daily for up to 6 months
Outcomes
Primary Outcome Measures
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Secondary Outcome Measures
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Full Information
NCT ID
NCT00809965
First Posted
December 16, 2008
Last Updated
August 26, 2014
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00809965
Brief Title
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia, Unstable Angina
Keywords
Rivaroxaban, Acute Coronary Syndrome, ACS, Aspirin, Thienopyridine, Unstable Angina, Myocardial Infarction, Anticoagulation, Clopidogrel (Plavix)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15526 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivaroxaban 2.5 mg bid
Arm Type
Experimental
Arm Description
One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Arm Title
Rivaroxaban 5 mg bid
Arm Type
Experimental
Arm Description
One 5 mg rivaroxaban tablet twice daily for up to 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One placebo tablet twice daily for up to 6 months
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 2.5 mg
Intervention Description
One tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 5 mg
Intervention Description
One tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One placebo tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Standard of care
Primary Outcome Measure Information:
Title
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
Description
The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Time Frame
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary Outcome Measure Information:
Title
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
Description
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Time Frame
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Title
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
Description
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Time Frame
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Title
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
Description
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Time Frame
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Title
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
Description
The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
Time Frame
From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
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Birmingham
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Alabama
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Geneva
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Chile
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Chile
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China
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Beijing
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Colombia
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Envigado
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Colombia
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Manizales
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Colombia
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Santander
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Croatia
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Benesov Nad Cernou
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Czech Republic
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Brno
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Czech Republic
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Czech Republic
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Czech Republic
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Hradec Kralove
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Czech Republic
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Kolin N/A
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Czech Republic
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Kromeriz
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Czech Republic
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Litomysl
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Czech Republic
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Czech Republic
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Plzeò 1
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Czech Republic
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Poruba
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Czech Republic
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Czech Republic
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Praha 2
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Czech Republic
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Praha 8
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Czech Republic
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Praha
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Czech Republic
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Slany
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Czech Republic
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Teplice
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Czech Republic
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Usti Nad Labem
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Czech Republic
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Znojmo N/A
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Czech Republic
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Aalborg
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Denmark
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Esbjerg
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Denmark
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Holbæk
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Denmark
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Horsens N/A
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Denmark
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Kolding
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Denmark
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København
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Denmark
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Odense
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Denmark
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Alexandria
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Egypt
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Cairo
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Egypt
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Ismailia
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Egypt
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Egypt
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Besancon
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France
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Cannes
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France
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Chambray-Les-Tours
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France
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Chartres
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France
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Creteil N/A
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France
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Dijon
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France
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Haguenau
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France
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Lagny
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France
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Marseille
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France
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Montfermeil
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France
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Paris
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France
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Poitiers
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France
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Bad Friedrichshall
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Germany
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Germany
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Esslingen
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Germany
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Germany
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Freiburg
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Germany
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Mannheim
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Greece
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Larisa
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Greece
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Rhodes
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Greece
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Greece
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Győr
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Hungary
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Kecskemet
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Hungary
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Szolnok
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Zalaegerszeg
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Ahmedabad
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India
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India
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India
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India
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India
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India
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India
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India
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India
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Hyderabad
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India
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Jaipur
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India
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Karamsad
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India
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Kochi
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India
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Kolkata
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Madurai
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Mangalore
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India
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Mumbai
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India
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Mysore
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India
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Nagpur
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Nasik
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India
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New Delhi
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India
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Pune
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India
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Surat
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India
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Trissur
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India
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Trivandrum
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India
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Vadodara
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India
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Vijayawada
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India
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Afula
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Nahariya
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Israel
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Petah Tikva
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Israel
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Rehovot
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Israel
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Safed
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Israel
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Tel Aviv
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Israel
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Tiberias
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Israel
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Anan
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Japan
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Fukui
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Japan
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Fukuoka-Shi,
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Japan
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Fukuyama-City,
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Japan
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Gifu-City
Country
Japan
City
Higashiosaka-City
Country
Japan
City
Kagoshima-City
Country
Japan
City
Kanazawa-City
Country
Japan
City
Kasuga
Country
Japan
City
Kawachinagano-City
Country
Japan
City
Kawasaki-City
Country
Japan
City
Kisarazu-City
Country
Japan
City
Kobe-City
Country
Japan
City
Kobe-Shi
Country
Japan
City
Kumamoto-City
Country
Japan
City
Kumamoto
Country
Japan
City
Kuwana-City
Country
Japan
City
Maebashi-City Gunma
Country
Japan
City
Matsudo-City
Country
Japan
City
Matsumoto
Country
Japan
City
Matsuyama-City Ehime
Country
Japan
City
Miyazaki-Gun
Country
Japan
City
Nagano-City
Country
Japan
City
Nagasaki
Country
Japan
City
Nagoya-City
Country
Japan
City
Nagoya
Country
Japan
City
Namegata-City
Country
Japan
City
Nankoku-City
Country
Japan
City
Nishinomiya
Country
Japan
City
Okayama-City
Country
Japan
City
Osaka-City
Country
Japan
City
Osaka
Country
Japan
City
Sakaide-City
Country
Japan
City
Sakura-Shi
Country
Japan
City
Suwa-City
Country
Japan
City
Tokushima-City
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo,
Country
Japan
City
Tokyo
Country
Japan
City
Toyama-City
Country
Japan
City
Urasoe-City
Country
Japan
City
Yamaguchi
Country
Japan
City
Yokohama N/A
Country
Japan
City
Yokohama-City
Country
Japan
City
Yokohama-Shi
Country
Japan
City
Yokohama
Country
Japan
City
Yonago-Shi
Country
Japan
City
Daejeon
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Seognam-Si, Kyungki-Do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Suwon
Country
Korea, Republic of
City
Daugavpils
Country
Latvia
City
Liepaja
Country
Latvia
City
Riga
Country
Latvia
City
Kaunas
Country
Lithuania
City
Klaipeda
Country
Lithuania
City
Siauliai
Country
Lithuania
City
Vilnius Lt
Country
Lithuania
City
Vilnius
Country
Lithuania
City
Johor Bahru
Country
Malaysia
City
Kelantan
Country
Malaysia
City
Kota Samarahan
Country
Malaysia
City
Kuala Lumpur
Country
Malaysia
City
Selayang N/A
Country
Malaysia
City
Aguascalientes
Country
Mexico
City
Cd. Juarez
Country
Mexico
City
Ciudad De Mexico
Country
Mexico
City
Culiacan
Country
Mexico
City
Guadalajara
Country
Mexico
City
Leon
Country
Mexico
City
Mexico
Country
Mexico
City
Monterrey
Country
Mexico
City
Queretaro
Country
Mexico
City
San Luis Potosi
Country
Mexico
City
Sinaloa
Country
Mexico
City
Veracruz
Country
Mexico
City
Zapopan
Country
Mexico
City
Marrakech
Country
Morocco
City
Meknès
Country
Morocco
City
Rabat
Country
Morocco
City
Amsterdam
Country
Netherlands
City
Arnhem
Country
Netherlands
City
Delft
Country
Netherlands
City
Den Haag
Country
Netherlands
City
Eindhoven
Country
Netherlands
City
Gorinchem
Country
Netherlands
City
Gouda
Country
Netherlands
City
Haarlem
Country
Netherlands
City
Harderwijk
Country
Netherlands
City
Hengelo Ov
Country
Netherlands
City
Nieuwegein
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
Sittard
Country
Netherlands
City
Vlaardingen
Country
Netherlands
City
Auckland
Country
New Zealand
City
Dunedin
Country
New Zealand
City
Hamilton
Country
New Zealand
City
Lower Hutt
Country
New Zealand
City
Nelson
Country
New Zealand
City
New Plymouth
Country
New Zealand
City
Iloilo City
Country
Philippines
City
Marikina City
Country
Philippines
City
Quezon City
Country
Philippines
City
Bedzin
Country
Poland
City
Białystok
Country
Poland
City
Bielsko-Biala
Country
Poland
City
Bydgoszcz
Country
Poland
City
Bytom
Country
Poland
City
Dąbrowa Górnicza
Country
Poland
City
Gdynia
Country
Poland
City
Gorlice
Country
Poland
City
Katowice N/A
Country
Poland
City
Katowice-Ochojec
Country
Poland
City
Katowice
Country
Poland
City
Koszalin
Country
Poland
City
Krakow N/A
Country
Poland
City
Krakow
Country
Poland
City
Kutno
Country
Poland
City
Lodz
Country
Poland
City
Nowy Targ
Country
Poland
City
Opole
Country
Poland
City
Plock
Country
Poland
City
Poznan N/A
Country
Poland
City
Poznan
Country
Poland
City
Ruda Slaska
Country
Poland
City
Starogard Gdanski Nap
Country
Poland
City
Szczecin N/A
Country
Poland
City
Szczecin
Country
Poland
City
Torun
Country
Poland
City
Warszawa N/A
Country
Poland
City
Warszawa
Country
Poland
City
Wloclawek
Country
Poland
City
Wroclaw
Country
Poland
City
Zamosc
Country
Poland
City
Aveiro
Country
Portugal
City
Braga
Country
Portugal
City
Coimbra
Country
Portugal
City
Faro
Country
Portugal
City
Leiria
Country
Portugal
City
Lisboa
Country
Portugal
City
Penafiel
Country
Portugal
City
Porto
Country
Portugal
City
Vila Nova De Gaia
Country
Portugal
City
Bucuresti
Country
Romania
City
Craiova
Country
Romania
City
Focsani
Country
Romania
City
Oradea
Country
Romania
City
Pitesti
Country
Romania
City
Tg Mures
Country
Romania
City
Timisoara
Country
Romania
City
Arkhangelsk
Country
Russian Federation
City
Barnaul
Country
Russian Federation
City
Chelyabinsk
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Ivanovo
Country
Russian Federation
City
Kaliningrad
Country
Russian Federation
City
Kemerovo
Country
Russian Federation
City
Kirov
Country
Russian Federation
City
Krasnodar
Country
Russian Federation
City
Krasnoyarsk
Country
Russian Federation
City
Kursk
Country
Russian Federation
City
Lyubertsy
Country
Russian Federation
City
Moscow N/A
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Nizhny Novgorod
Country
Russian Federation
City
Novosibirsk
Country
Russian Federation
City
Omsk
Country
Russian Federation
City
Orenburg
Country
Russian Federation
City
Penza
Country
Russian Federation
City
Perm
Country
Russian Federation
City
Pskov
Country
Russian Federation
City
Pushkin, Saint-Petersburg
Country
Russian Federation
City
Ryazan
Country
Russian Federation
City
Saint-Petersbrug
Country
Russian Federation
City
Saint-Petersburg
Country
Russian Federation
City
Sestroretsk, Saint-Petersburg
Country
Russian Federation
City
St Petersburg N/A
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
St. Petersburg
Country
Russian Federation
City
Syktyvkar
Country
Russian Federation
City
Tomsk
Country
Russian Federation
City
Tula
Country
Russian Federation
City
Tumen Region
Country
Russian Federation
City
Vladimir
Country
Russian Federation
City
Voronezh
Country
Russian Federation
City
Yaroslavl Nap
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Beograd
Country
Serbia
City
Kragujevac
Country
Serbia
City
Niska Banja
Country
Serbia
City
Nis
Country
Serbia
City
Bratislava
Country
Slovakia
City
Nové Zámky
Country
Slovakia
City
Zilina
Country
Slovakia
City
Alicante N/A
Country
Spain
City
Aviles Asturias
Country
Spain
City
Barcelona
Country
Spain
City
Burgos
Country
Spain
City
Elche
Country
Spain
City
Figueres
Country
Spain
City
Guadalajara
Country
Spain
City
Huelva N/A
Country
Spain
City
Madrid
Country
Spain
City
Malaga
Country
Spain
City
Málaga
Country
Spain
City
Salamanca
Country
Spain
City
Santander
Country
Spain
City
Sevilla
Country
Spain
City
Tarragona
Country
Spain
City
Valencia
Country
Spain
City
Vigo
Country
Spain
City
Danderyd
Country
Sweden
City
Göteborg
Country
Sweden
City
Jönköping
Country
Sweden
City
Linköping
Country
Sweden
City
Lund
Country
Sweden
City
Malmö
Country
Sweden
City
Umeå
Country
Sweden
City
Örebro
Country
Sweden
City
Östersund
Country
Sweden
City
Bangkok
Country
Thailand
City
Chiang Mai
Country
Thailand
City
Pathumthani
Country
Thailand
City
Phathumwan
Country
Thailand
City
Sfax
Country
Tunisia
City
Sousse
Country
Tunisia
City
Tunis
Country
Tunisia
City
Ankara
Country
Turkey
City
Aydin
Country
Turkey
City
Bursa
Country
Turkey
City
Erzurum
Country
Turkey
City
Istanbul
Country
Turkey
City
Izmir
Country
Turkey
City
Kayseri
Country
Turkey
City
Samsun
Country
Turkey
City
Sivas
Country
Turkey
City
Cherkassy
Country
Ukraine
City
Dnepropetrovsk
Country
Ukraine
City
Donetsk
Country
Ukraine
City
Ivano-Frankivsk
Country
Ukraine
City
Kharkov
Country
Ukraine
City
Khemelnitskiy
Country
Ukraine
City
Kiev
Country
Ukraine
City
Lugansk
Country
Ukraine
City
Lutsk
Country
Ukraine
City
Lviv
Country
Ukraine
City
Nikolaev
Country
Ukraine
City
Poltava
Country
Ukraine
City
Sumy
Country
Ukraine
City
Ternopol
Country
Ukraine
City
Uzhgorod
Country
Ukraine
City
Vinnitsa
Country
Ukraine
City
Zaporozhye
Country
Ukraine
City
Zhytomir
Country
Ukraine
City
Birmingham
Country
United Kingdom
City
Blackpool
Country
United Kingdom
City
Bristol
Country
United Kingdom
City
Chertsey
Country
United Kingdom
City
Chesterfield
Country
United Kingdom
City
East Sussex
Country
United Kingdom
City
Exeter
Country
United Kingdom
City
Hampshire
Country
United Kingdom
City
Harrow
Country
United Kingdom
City
Hull
Country
United Kingdom
City
Leicester
Country
United Kingdom
City
Lincoln
Country
United Kingdom
City
Manchester
Country
United Kingdom
City
Middlesbrough
Country
United Kingdom
City
Portadown
Country
United Kingdom
City
Stockport
Country
United Kingdom
City
Warwick
Country
United Kingdom
City
Worcester
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31535314
Citation
Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
Results Reference
derived
PubMed Identifier
29976285
Citation
Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.
Results Reference
derived
PubMed Identifier
25318481
Citation
Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.
Results Reference
derived
PubMed Identifier
23602776
Citation
Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.
Results Reference
derived
PubMed Identifier
23500262
Citation
Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.
Results Reference
derived
PubMed Identifier
22077192
Citation
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. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.
Results Reference
derived
PubMed Identifier
21570509
Citation
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. doi: 10.1016/j.ahj.2011.01.026.
Results Reference
derived
Learn more about this trial
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
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