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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00714961




Registration number
NCT00714961
Ethics application status
Date submitted
10/07/2008
Date registered
14/07/2008
Date last updated
25/03/2009

Titles & IDs
Public title
Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
Scientific 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
Secondary ID [1] 0 0
CV149-015
Secondary ID [2] 0 0
EFC5133
Universal Trial Number (UTN)
Trial acronym
CLARITY-TIMI28
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel (SR25990)
Treatment: Drugs - Placebo

Experimental: 1 -

Placebo comparator: 2 -


Treatment: Drugs: Clopidogrel (SR25990)
plus acetylsalicylic acid (ASA)

Treatment: Drugs: Placebo
plus acetylsalicylic acid (ASA)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Primary outcome [2] 0 0
safety: TIMI major bleeding
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Angiographic, clinical and electrocardiographic outcomes
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* STEMI within 12 hours of randomization
* Planned treatment with a fibrinolytic agent and aspirin
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2005
Sample size
Target
Accrual to date
Final
3491
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New Jersey
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Austria
State/province [3] 0 0
Vienna
Country [4] 0 0
Belgium
State/province [4] 0 0
Diegem
Country [5] 0 0
Brazil
State/province [5] 0 0
Sao Paulo
Country [6] 0 0
Canada
State/province [6] 0 0
Laval
Country [7] 0 0
France
State/province [7] 0 0
Paris
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Israel
State/province [11] 0 0
Natanya
Country [12] 0 0
Italy
State/province [12] 0 0
Milano
Country [13] 0 0
Mexico
State/province [13] 0 0
Mexico
Country [14] 0 0
Netherlands
State/province [14] 0 0
Gouda
Country [15] 0 0
Poland
State/province [15] 0 0
Warszawa
Country [16] 0 0
Portugal
State/province [16] 0 0
Porto
Country [17] 0 0
Puerto Rico
State/province [17] 0 0
Puerto Rico
Country [18] 0 0
Russian Federation
State/province [18] 0 0
Moscow
Country [19] 0 0
South Africa
State/province [19] 0 0
Midrand
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Sweden
State/province [21] 0 0
Bromma
Country [22] 0 0
Turkey
State/province [22] 0 0
Istanbul
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Guildford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00714961
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Eugene Braunwald, MD
Address 0 0
Brigham and Women's Hospital, Boston, MA, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00714961