Status:
COMPLETED
Safety and Efficacy of Three Different Loading Doses of Clopidogrel, in Patients With Acute Myocardial Infarction
Lead Sponsor:
Ospedale San Donato
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this study is to determine both safety and effectiveness of three different loading dose regimens of clopidogrel in patients with acute myocardial infarction undergoing primary angioplasty.
Detailed Description
This study will enroll STEMI patients, who were planned to undergo PCI, and will randomize them to three different clopidogrel loading dose regimens at first medical contact: no pre-treatment, 600 mg ...
Eligibility Criteria
Inclusion
- ST-elevation myocardial infarction:
- chest pain lasting more than 30 minutes
- not responsive to nitrates
- ST-segment elevation of more than 0.1 mV in two or more leads on the ECG, or new Left Bundle Branch Block
- With indication to primary PCI, presenting within 12 hour from symptoms onset
- Age \> 18 years
- Planned PCI
- Informed Consent
Exclusion
- bleeding diathesis
- allergy to study drugs
- pregnancy
- the performance of a rescue PCI after thrombolysis
- known existence of a disease resulting in a life expectancy of \<6 months
- lack of informed consent
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00882739
Start Date
April 1 2009
Last Update
January 26 2012
Active Locations (1)
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1
Cardiovascular Department, Ospedale S.Donato
Arezzo, AR, Italy, 52100