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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Percutaneous Coronary Intervention (PCI); Coronary Arterial Disease (CAD)
• Intervention / Treatment: Drug: Prasugrel 5 mg; Drug: Dual Antiplatelet (DAPT) Therapy

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Prof José P.S. Henriques; Phone Number: 020 566 9111; Email: cardiol@amsterdamumc.nl
    • Principal Investigator: José P.S. Henriques, MD, PhD
    • Sub-Investigator: Shabiga Sivanesan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Prasugrel low-dose monotherapy	Drug: Prasugrel 5 mg; Prasugrel 5 mg once daily (monotherapy)
Active Comparator: Control Arm; Dual antiplatelet therapy	Drug: Dual Antiplatelet (DAPT) Therapy; Dual antiplatelet therapy according to guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: J.P.S Henriques

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Piperazines; Prasugrel Hydrochloride; Therapeutics; 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine
• Other Study ID Numbers: PROMOTE; 2024-520351-24-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No