A Randomised Comparison Between 150 mg/die Clopidogrel Maintenance Dose Versus 75 mg/die in Patients with ST Segment Elevation Acute Myocardial Infarction: Effects on Platelet Aggregation and Inflammatory Markers - ND
- Conditions
- ST Segment Elevation Acute Myocardial InfarctionMedDRA version: 6.1Level: PTClassification code 10000891
- Registration Number
- EUCTR2007-002664-10-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients with ST segment elevation acute myocardial infarction treated with primary PCI within 12 hours of symptoms onset. Age>18 years No complications during the procedure Informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Shock High risk of bleeding Severe comorbidities with life expectancy < 1 year Pregnant women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The object of the present study is to asses the antiplatelet effect of a maintenance dose of 150 mg/die compared to the classical dose of 75 mg/die in patients with ST segment elevation acute myocardial infarction treated with percutaneous coronary intervention (PCI);Secondary Objective: considering the close relations existing between platelets and inflammatory cells, we will evaluate the effect of the higher dose on several inflammatory markers;Primary end point(s): The primary end point of the study is maximal aggregation after stimulus with 20 mol/L ADP 30 days after randomisation on platelet rich plasma using the optical method
- Secondary Outcome Measures
Name Time Method