Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Non ST Segment Elevation Acute Coronary Syndrome Clinical Trial

— OPTICA  

Official title:

Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766437
• Other study ID #: OPTICA
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2021
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy using a potent P2Y12-inhibitor such as prasugrel or ticagrelor. Objective: This study will serve as a pilot to investigate the feasibility and safety of a single antiplatelet strategy with prasugrel or ticagrelor prior to, during and after stent implantation in 75 patients with non-ST segment elevation acute coronary syndrome. Study design: Single-center, single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis. Study population: Patients presenting with non-ST segment elevation acute coronary syndrome and (a) 'de novo' lesion(s) treated with new generation drug-eluting stent(s) with adequate reduction of platelet reactivity according to platelet function testing with VerifyNow and optimal stenting result adjudicated by optical coherence tomography or coronary angiography. Intervention: Once daily 10 mg prasugrel or twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 60 mg prasugrel or 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy. Main study endpoint: The primary ischemic endpoints is the composite of all-cause mortality, myocardial infarction, Academic Research Consortium defined stent thrombosis and ischemic stroke at 6 months after percutaneous coronary intervention. The primary bleeding outcome is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 6 months after percutaneous coronary intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 3, 2023
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• NSTE-ACS diagnosis
• 'De novo' coronary lesion(s) eligible for PCI
• Written informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Non ST Segment Elevation Acute Coronary Syndrome

Intervention

Drug:
• Prasugrel 10mg
Once daily 10 mg prasugrel for 12 months preceded by a loading dose of 60 mg prasugrel at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.
• Ticagrelor 90mg
Twice daily 90 mg ticagrelor for 12 months preceded by a loading dose of 180 mg ticagrelor at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary ischemic endpoint	Number of participants with primary ischemic endpoint defined as composite of all-cause mortality, myocardial infarction, Academic Research Consortium defined stent thrombosis and ischemic stroke	6 months
Primary	Primary bleeding endpoint	Number of participants with primary bleeding endpoint defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding	6 months