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Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction (CLARITY-TIMI28)

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Clopidogrel (SR25990)
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndromes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • sanofi-aventis Austria
  • sanofi-aventis Belgium
  • sanofi-aventis Brazil
  • sanofi-aventis Canada
  • sanofi-aventis France
  • sanofi-aventis Germany
  • Sanofi-Aventis Hungaria
  • Sanofi-Aventis
  • Sanofi-Aventis
  • sanofi-aventis Italy
  • Sanofi-Aventis Mexico
  • sanofi-aventis Netherlands
  • sanofi-aventis Poland
  • Sanofi-Aventis
  • Sanofi-Aventis
  • Sanofi-Aventis
  • sanofi-aventis South Africa
  • sanofi-aventis Spain
  • sanofi-aventis Sweden
  • Sanofi-Aventis
  • sanofi-aventis UK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

Angiographic, clinical and electrocardiographic outcomes

Full Information

First Posted
July 10, 2008
Last Updated
March 24, 2009
Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00714961
Brief Title
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
Acronym
CLARITY-TIMI28
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Clopidogrel Plus Acetylsalicylic Acid (ASA) Versus ASA Alone in Subjects With Acute ST Elevation Myocardial Infarction (STEMI) Treated With Fibrinolytic Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3491 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Clopidogrel (SR25990)
Intervention Description
plus acetylsalicylic acid (ASA)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
plus acetylsalicylic acid (ASA)
Primary Outcome Measure Information:
Title
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
Title
safety: TIMI major bleeding
Secondary Outcome Measure Information:
Title
Angiographic, clinical and electrocardiographic outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: STEMI within 12 hours of randomization Planned treatment with a fibrinolytic agent and aspirin Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Braunwald, MD
Organizational Affiliation
Brigham and Women's Hospital, Boston, MA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis
City
Buenos Aires
Country
Argentina
Facility Name
Sanofi-Aventis
City
Macquarie Park
Country
Australia
Facility Name
sanofi-aventis Austria
City
Vienna
Country
Austria
Facility Name
sanofi-aventis Belgium
City
Diegem
Country
Belgium
Facility Name
sanofi-aventis Brazil
City
Sao Paulo
Country
Brazil
Facility Name
sanofi-aventis Canada
City
Laval
Country
Canada
Facility Name
sanofi-aventis France
City
Paris
Country
France
Facility Name
sanofi-aventis Germany
City
Berlin
Country
Germany
Facility Name
Sanofi-Aventis Hungaria
City
Budapest
Country
Hungary
Facility Name
Sanofi-Aventis
City
Dublin
Country
Ireland
Facility Name
Sanofi-Aventis
City
Natanya
Country
Israel
Facility Name
sanofi-aventis Italy
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Mexico
City
Mexico
Country
Mexico
Facility Name
sanofi-aventis Netherlands
City
Gouda
Country
Netherlands
Facility Name
sanofi-aventis Poland
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis
City
Porto
Country
Portugal
Facility Name
Sanofi-Aventis
City
Puerto Rico
Country
Puerto Rico
Facility Name
Sanofi-Aventis
City
Moscow
Country
Russian Federation
Facility Name
sanofi-aventis South Africa
City
Midrand
Country
South Africa
Facility Name
sanofi-aventis Spain
City
Barcelona
Country
Spain
Facility Name
sanofi-aventis Sweden
City
Bromma
Country
Sweden
Facility Name
Sanofi-Aventis
City
Istanbul
Country
Turkey
Facility Name
sanofi-aventis UK
City
Guildford
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15758000
Citation
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.
Results Reference
result
PubMed Identifier
20102867
Citation
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.
Results Reference
derived

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Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction

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