ST Segment Elevation Acute Myocardial Infarction MedDRA version: 6.1 Level: PT Classification code 10000891
Conditions
Interventions
Trade Name: PLAVIX*28CPR RIV 75MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Clopidogrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Shock High risk of bleeding Severe comorbidities with life expectancy < 1 year Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed