Non-ST elevation acute coronary syndrome (coronary artery disease)
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Tablet
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older are eligible for inclusion if all of the following criteria are met: - Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina) - Successful PCI (according to the treating physician) with implantation of new generation drugeluting stents. - CYP2C19 extensive metabolizer 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Known allergy or contraindication for aspirin or clopidogrel. - Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation) - Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS) - High-risk features for PCI including left main disease, chronic total occlusion, bifurcation lesion requiring 2-stent treatment, saphenous or arterial graft lesion, severely calcified lesion requiring the use of the Rotablator system, =3 treated vessels, = 3 stents implanted and total stent length >60 mm. - Recent stroke, transient ischemic attack (TIA) or intracranial bleeding - Severe hepatic impairment - Planned surgical intervention within 12 months of PCI - Pregnant or breastfeeding women at time of enrolment - Participation in another trial with an investigational drug or device • Patients requiring staged procedure (to avoid heterogeneity in the duration of pharmacological treatment between index and staged procedures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy endpoint is to assess ischemic risk of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients. The primary safety endpoint is to assess bleeding risk of genotype-guided clopidogrel monotherapy during the first 6 months following successful PCI in NSTE-ACS patients. ;Secondary Objective: The secondary endpoints include the individual components of the primary safety and efficacy endpoints (at 3 and 6 months).;Primary end point(s): The primary ischemic endpoints at 6 months is the composite of: •All-cause mortality •Myocardial infarction •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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will include: • Primary ischemic and bleeding endpoint at 3 months • Each individual component of the primary endpoints at 3 and 6 months • Cardiovascular mortality at 3 and 6 months • Non-cardiovascular mortality at 3 and 6 months • Any need for revascularization at 3 and 6 months • Any periprocedural complications ;Timepoint(s) of evaluation of this end point: 3 and 6 months | — |
Countries
Netherlands
Contacts
Public ContactR&I Cardiology
St. Antonius Hospital
Outcome results
None listed