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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222573
First Posted: September 22, 2005
Last Update Posted: May 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Sanofi
AstraZeneca
Information provided by:
University of Oxford
  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
Intervention Model: Factorial Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: May 5, 2006
Last Verified: March 2005

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
Clopidogrel
Ticlopidine
Metoprolol
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents