Status:
COMPLETED
CIPAMI-Study: Clopidogrel Administered Prehospital to Improve Primary PCI in Patients With Acute Myocardial Infarction
Lead Sponsor:
Stiftung Institut fuer Herzinfarktforschung
Collaborating Sponsors:
Bristol-Myers Squibb
Sanofi
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Acute myocardial infarction is generally caused by a thrombotic occlusion of coronary arteries. Primary aim of early therapy is a fast and complete reperfusion of the infarcted myocardium, which can b...
Eligibility Criteria
Inclusion
- Acute STEMI \<= 6 hrs.
- Planned percutaneous coronary intervention
- Age \>= 18 years
- Ability to understand the natures, scope, and possible consequences of the study / legal capacity
- Informed consent
Exclusion
- Thrombolytic therapy within 24 hours before randomization
- Effective oral or intravenous anticoagulation (INR\>2, or PTT\>2xcontrol)
- Known hemorrhagic diathesis
- Stroke or TIA within 3 months
- Evidence of an active gastrointestinal or urogenital bleeding
- Major surgery (including CABG) within 6 weeks
- Contraindication to Clopidogrel
- Severe renal or hepatic insufficiency
- Contraindication to coronary angiography
- Planned administration of a GP IIb/IIIa-Inhibitor before angiography
- Pregnant or nursing (lactating) women
- Women with childbearing potential
- Patients currently (within the last 10 days) treated with clopidogrel or ticlopidine
- Participation in another clinical or device trial within the previous 30 days
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00372216
Start Date
October 1 2006
End Date
January 1 2010
Last Update
November 19 2010
Active Locations (25)
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1
Universitaetsklinikum Innsbruck
Innsbruck, Austria, A-6020
2
Hanusch-Krankenhaus
Vienna, Austria, A-1140
3
Wilhelminenspital
Vienna, Austria, A-1171
4
Universitaetsklinikum Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167