ASSESSING THE EFFECTS OF SWITCHING THERAPY FROM CLOPIDOGREL TO PRASUGREL IN PATIENTS WITH ACUTE CORONARY SYNDROME ALREADY TREATED WITH CLOPIDOGRE
- Conditions
- STE-ACS undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedureMedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-001522-10-IT
- Lead Sponsor
- IVERSITA' CAMPUS BIOMEDICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Unstable angina or non ST-elevation myocardial infarction undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedure (chronic therapy with 75 mg / day for at least 5 days, 300 mg loading at least 12 hours, load of 600 mg of at least 6 hours).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Patients undergoing primary coronary angioplasty for myocardial infarction with ST-segment sovraslivellamento
2. Patients older than 75 years
3. Patients weighing less than 60 kg
4. Patients with a recent episode of major bleeding (<6 months)
5. Patients with platelet counts below 70 × 10 * 9 / L
6. Patients with recent or past history of stroke or transient ischemic attack
7. Patients with cardiac surgery or in the previous three months
8. Patients with anemia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of the study SWITCH is therefore to assess whether in patients with ACS without ST elevation, already treated with clopidogrel and undergoing stent implantation, a switch to prasugrel therapy might provide more protection from ischemic complications / thrombotic cardiac compared to standard therapy with clopidogrel.;Secondary Objective: nd;Primary end point(s): Incidence of major adverse cardiac events 30 days after procedure;Timepoint(s) of evaluation of this end point: 30 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Evaluation of peri-procedural residual platelet reactivity.<br> 2. Incidence of stent thrombosis at 30-days follow-up <br> 3. Incidence of bleeding complications according to the criteria TIMI (major bleeding: intracranial hemorrhage, or associated with a decrease in hemoglobin of 5 g / dL; minor bleeding: reduction of hemoglobin <5 g / dl) or access site complications (hematoma more of 10 cm, or femoral artery pseudoaneurysm arteriovenous fistulas).<br> 4. Evaluation of the expression of micro-RNA pre-and post-procedure in the four treatment arms.;Timepoint(s) of evaluation of this end point: 30 days