Trial Review

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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Sabatine MS, Cannon CP, Gibson CM, Lopez-Sendon JL... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00714961