Efficacy and Safety of Adding Clopidogrel to Aspirin or Use of Metoprolol in Myocardial Infarction

This study has been completed.
Sponsor:
Collaborators:
Sanofi
AstraZeneca
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00222573
First received: September 13, 2005
Last updated: May 4, 2006
Last verified: March 2005
  Purpose

COMMIT/CCS2 is a large randomised trial of the effects of clopidogrel plus Aspirin versus Aspirin alone in acute heart disease. Patients presenting within 24 hours of the onset of suspected acute MI were potentially eligible provided they were thought to have ST elevation or other ischaemic ECG abnormality with no clear indication for, or contraindication to, trial treatment. All patients were to be given 162 mg ASA daily and, in addition, 75 mg clopidogrel daily or matching placebo for 4 weeks or until prior discharge or death. (Patients were also randomised separately in a 2 X 2 factorial design between metoprolol versus placebo.) The two main study endpoints are death and the composite outcome of death, non-fatal reinfarction or stroke during the scheduled treatment period in hospital.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: clopidogrel and metoprolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clopidogrel Or Metoprolol in Myocardial Infarction Trial

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Death and the composite outcome of death, non-fatal reinfarction or stroke

Secondary Outcome Measures:
  • Major cardiovascular events

Estimated Enrollment: 46000
Study Start Date: July 1999
Estimated Study Completion Date: February 2005
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with ST elevation, left bundle branch block or ST depression within 24 hours of the onset of the symptoms of suspected acute MI

Exclusion Criteria:

  • clear indications for, or contraindications to, any of the study treatments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222573

Locations
China
Institute of Cadiovascular diseases, Fuwai hospital, Chinese academy of medical sciences
Beijing, China, 100037
United Kingdom
Clinical Trial Service Unit and Epidemiological Studies Unit
Oxford, United Kingdom, OX3 7LF
Sponsors and Collaborators
University of Oxford
Sanofi
AstraZeneca
Investigators
Study Chair: Rory Collins, Msc University of Oxford
Study Chair: Lisheng Liu, MD Institute of cardiovascular diseases, Fuwai hospital, Chinese academy of medical sciences
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00222573     History of Changes
Other Study ID Numbers: COMMIT-CCS2, H6RDCN0
Study First Received: September 13, 2005
Last Updated: May 4, 2006
Health Authority: China: Ministry of Health

Keywords provided by University of Oxford:
clopidogrel
metoprolol
myocardial infarction
randomised trial

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Metoprolol succinate
Clopidogrel
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on April 23, 2014