NSTE-ACS undergoing coronary angioplasty, already treated with clopidogrel in combination with aspirin at the time of the procedure MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: EFIENT*28CPR RIV 10MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: PRASUGREL HYDROCHLORIDE
CAS Number: 389574-19-0
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
UNIVERSITA' CAMPUS BIOMEDICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Evaluation of peri-procedural residual platelet reactivity. 2. Incidence of stent thrombosis at 30-days follow-up 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). 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 | — |
Countries
Italy
Contacts
Public ContactCARDIOLOGIA
POLICLINICO UNIVERSITARIO CAMPUS BIO-MEDICO DI ROMA
Outcome results
None listed