Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)

J.P.S Henriques

Status and phase

Not yet enrolling

Phase 4

Conditions

Coronary Arterial Disease (CAD)

Percutaneous Coronary Intervention (PCI)

Treatments

Drug: Prasugrel 5 mg

Drug: Dual Antiplatelet (DAPT) Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06916520

2024-520351-24-00 (EU Trial (CTIS) Number)

PROMOTE

Details and patient eligibility

About

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI). However, this therapy is also associated with a higher risk of bleeding. Given the advances in stent technology and pharmacology, it may be possible to treat patients undergoing PCI with low dose prasugrel as single antiplatelet therapy, regardless of medical history, age or body weight.

Objective: Assess the feasibility and safety of a single antiplatelet strategy with a reduced dose of prasugrel 5 mg after PCI in acute and chronic coronary syndrome patients (ACS and CCS).

Study design: Open-label, single-centre, randomized controlled trial pilot.

Study population: Patients undergoing successful PCI due to acute or chronic coronary syndrome.

Intervention: A once-daily reduced dose of 5 mg prasugrel for 6 months in CCS patients and for 12 months in ACS patients, preceded by a loading dose of 60 mg prasugrel after PCI, administered without concomitant use of aspirin.

Main study parameters/endpoints: The primary endpoint is Net Adverse Clinical Events (NACE), a composite of all-cause death, myocardial infarction, definite stent thrombosis, ischemic stroke, clinically relevant non-major bleeding or major bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Acute Coronary Syndrome
Chronic Coronary Syndrome
Successful PCI

Exclusion criteria

Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
Current indication for oral anticoagulant therapy (OAC)
Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
Pregnancy or breast-feeding women
Participation in another trial with an investigational drug or device
Recent or ongoing strong CYP3A4 inhibitor or inducer therapy (e.g. clarithromycin, ketoconazole, carbamazepine or rifampicin)