Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

NCT04766437 | Completed Phase 2 DMC

• 1 other identifier: OPTICA
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

Non ST Segment Elevation Acute Coronary Syndrome; Percutaneous coronary intervention; Prasugrel monotherapy; Ticagrelor monotherapy; P2Y12-inhibitor monotherapy

Outcome Measures

Primary Outcomes (2)

• 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 bleeding endpoint

  Number of participants with primary bleeding endpoint defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding

  6 months

Study Arms (1)

Prasugrel or ticagrelor monotherapy

EXPERIMENTAL

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; Drug: Ticagrelor 90mg

Interventions

Prasugrel 10mg DRUG

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.

Prasugrel or ticagrelor monotherapy

Ticagrelor 90mg DRUG

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.

Prasugrel or ticagrelor monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Interventions

Prasugrel Hydrochloride; Ticagrelor

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm pilot study

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 23, 2021
• Study Start: February 19, 2021
• Primary Completion: September 3, 2022
• Study Completion: March 3, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Locations

NL (1)