Clinical trial NCT00714961: Clopidogrel as Adjunctive Reperfusion Therapy - Thrombolysis in Myocardial Infarction
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndromes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-07-14
Enrollment: 3491
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
measure: safety: TIMI major bleeding
Secondary outcomes:
measure: Angiographic, clinical and electrocardiographic outcomes
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis
city: Vienna
country: Austria
facility: sanofi-aventis Austria
city: Diegem
country: Belgium
facility: sanofi-aventis Belgium
city: Sao Paulo
country: Brazil
facility: sanofi-aventis Brazil
city: Laval
country: Canada
facility: sanofi-aventis Canada
city: Paris
country: France
facility: sanofi-aventis France
city: Berlin
country: Germany
facility: sanofi-aventis Germany
city: Budapest
country: Hungary
facility: Sanofi-Aventis Hungaria
city: Dublin
country: Ireland
facility: Sanofi-Aventis
city: Natanya
country: Israel
facility: Sanofi-Aventis
city: Milano
country: Italy
facility: sanofi-aventis Italy
city: Mexico
country: Mexico
facility: Sanofi-Aventis Mexico
city: Gouda
country: Netherlands
facility: sanofi-aventis Netherlands
city: Warszawa
country: Poland
facility: sanofi-aventis Poland
city: Porto
country: Portugal
facility: Sanofi-Aventis
city: Puerto Rico
country: Puerto Rico
facility: Sanofi-Aventis
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis
city: Midrand
country: South Africa
facility: sanofi-aventis South Africa
city: Barcelona
country: Spain
facility: sanofi-aventis Spain
city: Bromma
country: Sweden
facility: sanofi-aventis Sweden
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
city: Guildford
country: United Kingdom
facility: sanofi-aventis UK
Study officials:
affiliation: Brigham and Women's Hospital, Boston, MA, USA
name: Eugene Braunwald, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.