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

NCT06916520 | Recruiting Phase 4 DMC

• 2 other identifiers: PROMOTE2024-520351-24-00
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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. 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)

Outcome Measures

Primary Outcomes (1)

• NACE (Net Adverse Clinical Events)

  The primary endpoint is NACE, a composite of all-cause mortality, myocardial infarction, definite stent thrombosis, ischemic stroke, major bleeding or clinically relevant non-major bleeding defined as BARC type 2, 3 or 5

  12 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Prasugrel low-dose monotherapy

Drug: Prasugrel 5 mg

Control Arm

ACTIVE COMPARATOR

Dual antiplatelet therapy

Drug: Dual Antiplatelet (DAPT) Therapy

Interventions

Prasugrel 5 mg DRUG

Prasugrel 5 mg once daily (monotherapy)

Intervention Arm

Dual Antiplatelet (DAPT) Therapy DRUG

Dual antiplatelet therapy according to guidelines

Control Arm

Eligibility Criteria

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

You may qualify if:

• Acute Coronary Syndrome
• Chronic Coronary Syndrome
• Successful PCI

You may not qualify if:

• 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 use of CYP2B6 substrates with a narrow therapeutic window (e.g. cyclophosphamide, efavirenz)

Sponsors & Collaborators

• J.P.S Henriques: lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Interventions

Prasugrel Hydrochloride; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Therapeutics

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: November 13, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

NL (1)