Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Study Overview
=================
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.

Official Title
-----------------
Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

Conditions
-----------------
Non ST Segment Elevation Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Prasugrel 10mg
* Drug: Ticagrelor 90mg


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prasugrel or ticagrelor monotherapy<br>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<br>* 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.<br>Drug: Ticagrelor 90mg<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non ST Segment Elevation Acute Coronary Syndrome, Percutaneous coronary intervention, Prasugrel monotherapy, Ticagrelor monotherapy, P2Y12-inhibitor monotherapy