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OPTIMIZE-APT
NCT05418556Phase 4
Key facts
- Status
- Recruiting
- Start
- Oct 2022
- Primary completion
- Dec 2027
- Countries
- 1
- Sponsor
- Asan Medical Center
- Conditions
- coronary artery disease (CAD)
01
Overview
Phase 4, randomised, open-label trial of aspirin, clopidogrel, ticagrelor and prasugrel in coronary artery disease (CAD) (2 arms), sponsored by Asan Medical Center. Primary endpoints: Composite ischemic endpoint at 12 months, Net adverse clinical events at 12 months and 1 more. Started Oct 2022; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Conventional Arm
12 months of DAPT with aspirin plus clopidogrel (CCS) or potent P2Y12 inhibitor (ACS).
Tailored Arm
1 month (CCS) or 3 months (ACS) of DAPT followed by P2Y12 inhibitor monotherapy up to 12 months.
03
Who it enrols
Adult patients with coronary artery disease undergoing optimized drug-eluting stent implantation guided by intravascular imaging (IVUS or OCT), excluding those with high bleeding risk, recent stroke, or requiring long-term anticoagulation.
04
Endpoints
Primary
Composite ischemic endpoint
Net adverse clinical events
Clinically relevant bleeding
Secondary
Individual components of the composite ischemic endpoint
Cardiovascular death
Stroke
Individual BARC bleeding categories
Stent strut coverage in the OCT substudy
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