OPTICA: Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04766437

Collaborator

(none)

Enrollment

Location

Arm

24.4

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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, 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.

Condition or Disease	Intervention/Treatment	Phase
Non ST Segment Elevation Acute Coronary Syndrome	Drug: Prasugrel 10mg Drug: Ticagrelor 90mg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm pilot studySingle arm pilot study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Actual Study Start Date :

Feb 19, 2021

Anticipated Primary Completion Date :

Sep 3, 2022

Anticipated Study Completion Date :

Mar 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prasugrel or ticagrelor monotherapy 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.	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. Drug: 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.

Arm

Intervention/Treatment

Experimental: Prasugrel or ticagrelor monotherapy

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.

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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

Primary ischemic endpoint [6 months]
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
Primary bleeding endpoint [6 months]
Number of participants with primary bleeding endpoint defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)