Optical coherence tomography-guided PCI with single antiplatelet therapy

Phase 2

Completed

Conditions: 'acute coronary syndrome'
'heart attack'
10011082

Registration Number: NL-OMON55165

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary ischemic endpoints at 6 months is the composite of:<br /><br>- All-cause mortality<br /><br>- Myocardial infarction (according to the 4th universal definition of MI)<br /><br>- Academic Research Consortium (ARC) defined definite or probable stent<br /><br>thrombosis<br /><br>- Ischemic stroke<br /><br><br /><br>The primary bleeding endpoint at 6 months is:<br /><br>- Major or minor bleeding defined as Bleeding Academic Research Consortium<br /><br>(BARC) type 2, 3 or 5 bleeding</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are:<br /><br>- Primary ischemic and bleeding endpoint at 12 months<br /><br>- Each individual component of the primary endpoints at 6 and 12 months<br /><br>- Cardiovascular mortality at 6 and 12 months<br /><br>- Non-cardiovascular mortality at 6 and 12 months<br /><br>- Any need for revascularization at 6 and 12 months<br /><br>- Any periprocedural complications<br /><br>- On-treatment platelet reactivity at baseline</p><br>