NCT00222573

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 1999

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1999

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

May 5, 2006

Status Verified

March 1, 2005

First QC Date

September 13, 2005

Last Update Submit

May 4, 2006

Conditions

Acute Myocardial Infarction

Keywords

clopidogrelmetoprololmyocardial infarctionrandomised trial

Outcome Measures

Primary Outcomes (1)

  • Death and the composite outcome of death, non-fatal reinfarction or stroke

Secondary Outcomes (1)

  • Major cardiovascular events

Interventions

clopidogrel and metoprololDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • clear indications for, or contraindications to, any of the study treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Cadiovascular diseases, Fuwai hospital, Chinese academy of medical sciences

Beijing, 100037, China

Location

Clinical Trial Service Unit and Epidemiological Studies Unit

Oxford, OX3 7LF, United Kingdom

Location

Related Publications (4)

  • 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. doi: 10.1016/S0140-6736(05)67661-1.

    PMID: 16271643RESULT

  • 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.

    PMID: 1627164RESULT

  • Steingrimsson JA, Hanley DF, Rosenblum M. Improving precision by adjusting for prognostic baseline variables in randomized trials with binary outcomes, without regression model assumptions. Contemp Clin Trials. 2017 Mar;54:18-24. doi: 10.1016/j.cct.2016.12.026. Epub 2017 Jan 4.

    PMID: 28064029DERIVED

  • 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. doi: 10.1016/S0140-6736(05)67660-X.

    PMID: 16271642DERIVED

Related Links

MeSH Terms

Conditions

Myocardial Infarction

Interventions

ClopidogrelMetoprolol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAmines

Study Officials

  • Rory Collins, Msc

    University of Oxford

    STUDY CHAIR

  • Lisheng Liu, MD

    Institute of cardiovascular diseases, Fuwai hospital, Chinese academy of medical sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 1999

Study Completion

February 1, 2005

Last Updated

May 5, 2006

Record last verified: 2005-03

Locations

CN(1)GB(1)