Efficacy and Safety of Adding Clopidogrel to Aspirin or Use of Metoprolol in Myocardial Infarction - Full Text View

Sponsor:	University of Oxford
Collaborators:	Sanofi-Aventis AstraZeneca
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00222573

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:

MedlinePlus related topics: Heart Attack

Drug Information available for: Metoprolol Metoprolol Tartrate Metoprolol succinate Metoprolol fumarate Clopidogrel Bisulfate

U.S. FDA Resources

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-Aventis

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:

study website This link exits the ClinicalTrials.gov site

Publications:

Chen ZM, Pan HC, Chen YP, Peto R, Collins R, Jiang LX, Xie JX, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1622-32.

Hubner G, Golbik R, Meshalkina LE. A method for determination of transketolase activity based on the use of a pH indicator. Biochem Int. 1992 Mar;26(3):545-50.

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

Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, Collins R, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1607-21.

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 May 24, 2012