non-ST segment elevation acute coronary syndrome MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10071111 Term: Non ST segment elevation acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Prasugrel
Pharmaceutical Form: Film-coated tablet
Trade Name: Acetylsalicylic acid
Pharmaceutical Form: Tablet
Trade Name: Ticagrelor
Pharmaceutical Form: Tablet
Sponsors
AMC Medical Research B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age =18 years - NSTE-ACS diagnosis in accordance with relevant guidelines - ‘De novo’ coronary lesion(s) eligible for PCI using new generation drug-eluting stent and requiring revascularization according to relevant guidelines - 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Known allergy or contraindication for prasugrel or ticagrelor use - Concurrent use of oral anticoagulants (e.g. for atrial fibrillation) - Overwriting indication for DAPT (e.g. recent PCI or ACS) - Planned surgical intervention within 12 months of planned revascularization - PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions - Recent or ongoing treatment with a strong CYP3A4 inhibitor or inducer - Pregnant or breastfeeding women at time of enrolment - Participation in another trial with an investigational drug or device (i.e. stent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to, during and after PCI with a new generation DES in NSTE-ACS patients;Secondary Objective: The secondary objectives of this study are to: - Evaluate the occurrence of high on-treatment platelet reactivity in prasugrel- or ticagrelor-treated patients - Evaluate the periprocedural findings of OCT after coronary stent implantation in prasugrel- or ticagrelor-treated patients;Primary end point(s): The primary ischemic endpoints at 6 months is the composite of: - All-cause mortality - Myocardial infarction (according to the 4th universal definition of MI) - Academic Research Consortium (ARC) defined definite or probable stent thrombosis - Ischemic stroke The primary bleeding endpoint at 6 months is: - Major or minor bleeding defined as Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding;Timepoint(s) of evaluation of this end point: 6 months after PCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: - Primary ischemic and bleeding endpoint at 12 months - Each individual component of the primary endpoints at 6 and 12 months - Cardiovascular mortality at 6 and 12 months - Non-cardiovascular mortality at 6 and 12 months - Any need for revascularization at 6 and 12 months - Any periprocedural complications - On-treatment platelet reactivity at baseline;Timepoint(s) of evaluation of this end point: Baseline, 6 months, 12 months | — |
Countries
Netherlands
Contacts
Public ContactTrial coordinator
Amsterdam UMC - location AMC
Outcome results
None listed