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

NCT ID: NCT06916520

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-04-30

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Prasugrel low-dose monotherapy

Group Type: EXPERIMENTAL

Prasugrel 5 mg

Intervention Type: DRUG

Prasugrel 5 mg once daily (monotherapy)

Control Arm

Dual antiplatelet therapy

Group Type: ACTIVE_COMPARATOR

Dual Antiplatelet (DAPT) Therapy

Intervention Type: DRUG

Dual antiplatelet therapy according to guidelines

Interventions

Prasugrel 5 mg

Prasugrel 5 mg once daily (monotherapy)

Intervention Type: DRUG

Dual Antiplatelet (DAPT) Therapy

Dual antiplatelet therapy according to guidelines

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

J.P.S Henriques

OTHER

Sponsor Role: lead

Responsible Party

J.P.S Henriques

Professor Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

2024-520351-24-00

Identifier Type: CTIS

Identifier Source: secondary_id

PROMOTE

Identifier Type: -

Identifier Source: org_study_id