Status:
COMPLETED
Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Non ST Segment Elevation Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably,...
Eligibility Criteria
Inclusion
- NSTE-ACS diagnosis
- 'De novo' coronary lesion(s) eligible for PCI
- Written informed consent
Exclusion
- Known allergy or contraindication for prasugrel and ticagrelor use.
- Concurrent use of oral anticoagulants
- Overwriting indication for DAPT
- 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 strong CYP3A4 inhibitor or inducer therapy
- Recent or ongoing therapy with CYP4A4-substrates with a narrow therapeutic index
- Pregnant or breastfeeding women at time of enrolment
- Participation in another trial with an investigational drug or device (i.e. stent)
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04766437
Start Date
February 19 2021
End Date
March 3 2023
Last Update
March 6 2023
Active Locations (1)
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1
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ