Clinical trial NCT04766437: Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
Official title: Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot study
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Primary ischemic endpoint
timeFrame: 6 months
measure: Primary bleeding endpoint
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
Study officials:
References: