Troponin positive acute coronary syndrome after successful percutaneous coronary intervention with an indication for a standard treatment of 12 month with prasugrel MedDRA version: 19.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Clopidogrel
Other descriptive name: CLOPIDOGREL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Tr
Sponsors
Hospital of the University of Munich, Grosshadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with troponin positive ACS - Successful PCI (defined as a post PCI diameter stenosis =2) - A planned treatment of prasugrel for 12 month after the procedure - Written informed consent Are the trial subjects under 18? no 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 1500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1100
Exclusion criteria
Exclusion criteria: - Age 80 years - Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage - Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke - Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to the beginning of this clinical trial. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamines) for =7 days. - Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban) - Indication for major surgery (per decision of the treating physician) for the planned duration of the study - Simultaneous participation in another clinical trial that involveds the administration of an investigational medicinal drug within 30 days prior to the beginning of this clinical trial - Known or persistent abuse of medication, drugs or alcohol - Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator`s opinion - Evidence of significant active neuropsychiatric disease, in the investigator´s opinion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A Platelet function testing guided approach with a short-term (1 week) post hospital discharge prasugrel maintenance dose treatment and a switch-over to clopidogrel treatment in adequate responders to the drug is non-inferior to the currently recommended long-term (12 month) treatment with prasugrel in ACS patients undergoing PCI.;Secondary Objective: - Bleeding events with a grade >= 2 defined according to BARC criteria - Stent thrombosis (definite or probable) according to ARC (Academic Research Consortium) criteria - Incidence of urgent ischemia-driven revaccularization - Incidence of death from any cause - Pre-specified cost-effectiveness analysis on the economic impact of a platelet function testing guided tailored treatment for ACS patients - The individual ischemic components of the primary endpoint will be subject to the secondary endpoint analysis ;Primary end point(s): Combined ischemic and bleeding endpoint, which is a composite endpoint consisting of death from cardiovascular cause, myocardial infarction, stroke and bleeding grade >= 2 defined according to BARC (Bleeding Academic Research Consortium) criteria;Timepoint(s) of evaluation of this end point: The time points of evaluation will be Follow up 30 days, 6 month and 12 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The time points of evaluation will be Follow up 30 days, 6 month and 12 month.;Secondary end point(s): - Bleeding events with a grade >= 2 defined according to BARC criteria - Stent thrombosis (definite or probable) according to ARC (Academic Research Consortium) criteria - Incidence of ischemia-driven revascularization - Incidence of death from any cause - Pre-specified cost-effectiveness analysis on the economic impact of a platelet function testing guided tailored treatment for ACS patients - The individual ischemic components of the primary endpoint will be subject to the secondary endpoint analysis -- Incidence of cardiovascular death at 12 month -- Incidence of MI at 12 month -- Incidence of nonfatal stroke at 12 month | — |
Countries
Austria, Germany, Hungary, Poland
Contacts
Public ContactI. Med. Klinik und Poliklinik
Hospital of the University of Munich, Grosshadern
Outcome results
None listed