Optical coherence tomography-guided PCI with single antiplatelet therapy

Optical coherence tomography-guided PCI with single antiplatelet therapy - OPTICA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55165

Enrollment

Registered

2020-12-23

Start date

2021-03-04

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'acute coronary syndrome' 'heart attack'

Interventions

Prasugrel or ticagrelor monotherapy prior to, during and 12 months after percutaneous coronary intervention

Eligibility

Age

18 Years to 99 Years

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

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
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)