NCT00714961

Brief Summary

The purpose of this study is to determine if the combination of aspirin plus clopidogrel is more effective than aspirin alone in preventing another heart attack, chest pain, stroke or death in people who have already had a heart attack that was treated with fibrinolytic therapy.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
3,491

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2003

Geographic Reach
23 countries

23 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

February 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2008

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

1.9 years

First QC Date

July 10, 2008

Last Update Submit

March 24, 2009

Conditions

Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (2)

  • efficacy: composite of an included infarct-related artery on the pre-discharge angiogram, or death or recurrent MI by the time of the start of coronary angiography

  • safety: TIMI major bleeding

Secondary Outcomes (1)

  • Angiographic, clinical and electrocardiographic outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Clopidogrel (SR25990)

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Clopidogrel (SR25990)DRUG

plus acetylsalicylic acid (ASA)

1
PlaceboDRUG

plus acetylsalicylic acid (ASA)

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI within 12 hours of randomization
  • Planned treatment with a fibrinolytic agent and aspirin

You may not qualify if:

  • Intention of performing coronary angiography within 48 hours of fibrinolysis
  • Treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, or planned treatment with clopidogrel or ticlopidine.
  • Contraindication to fibrinolysis
  • Planned use of a glycoprotein IIb/IIIa inhibitor
  • Prior CABG
  • Evidence of cardiogenic shock or acute pulmonary edema requiring intubation or an intraaortic balloon pump
  • Known renal or hepatic insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Sanofi-Aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Buenos Aires, Argentina

Location

Sanofi-Aventis

Macquarie Park, Australia

Location

sanofi-aventis Austria

Vienna, Austria

Location

sanofi-aventis Belgium

Diegem, Belgium

Location

sanofi-aventis Brazil

São Paulo, Brazil

Location

sanofi-aventis Canada

Laval, Canada

Location

sanofi-aventis France

Paris, France

Location

sanofi-aventis Germany

Berlin, Germany

Location

Sanofi-Aventis Hungaria

Budapest, Hungary

Location

Sanofi-Aventis

Dublin, Ireland

Location

Sanofi-Aventis

Netanya, Israel

Location

sanofi-aventis Italy

Milan, Italy

Location

Sanofi-Aventis Mexico

México, Mexico

Location

sanofi-aventis Netherlands

Gouda, Netherlands

Location

sanofi-aventis Poland

Warsaw, Poland

Location

Sanofi-Aventis

Porto, Portugal

Location

Sanofi-Aventis

San Juan, Puerto Rico

Location

Sanofi-Aventis

Moscow, Russia

Location

sanofi-aventis South Africa

Midrand, South Africa

Location

sanofi-aventis Spain

Barcelona, Spain

Location

sanofi-aventis Sweden

Bromma, Sweden

Location

Sanofi-Aventis

Istanbul, Turkey (Türkiye)

Location

sanofi-aventis UK

Guildford, United Kingdom

Location

Related Publications (2)

  • Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL, Montalescot G, Theroux P, Claeys MJ, Cools F, Hill KA, Skene AM, McCabe CH, Braunwald E; CLARITY-TIMI 28 Investigators. Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation. N Engl J Med. 2005 Mar 24;352(12):1179-89. doi: 10.1056/NEJMoa050522. Epub 2005 Mar 9.

    PMID: 15758000RESULT

  • Harkness JR, Sabatine MS, Braunwald E, Morrow DA, Sloan S, Wiviott SD, Giugliano RP, Antman EM, Cannon CP, Scirica BM. Extent of ST-segment resolution after fibrinolysis adds improved risk stratification to clinical risk score for ST-segment elevation myocardial infarction. Am Heart J. 2010 Jan;159(1):55-62. doi: 10.1016/j.ahj.2009.10.033.

    PMID: 20102867DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Eugene Braunwald, MD

    Brigham and Women's Hospital, Boston, MA, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 10, 2008

First Posted

July 14, 2008

Study Start

February 1, 2003

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

PL(1)US(1)BR(1)ME(1)PR(1)PT(1)GB(1)SE(1)IT(1)DE(1)IE(1)HU(1)NL(1)BE(1)RU(1)ZA(1)ES(1)TU(1)AU(1)IL(1)AR(1)CA(1)FR(1)