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

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

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorJ.P.S Henriques

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute Coronary Syndrome

Chronic Coronary Syndrome

Successful PCI

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Prasugrel 5 mg
Drug
Prasugrel 5 mg once daily (monotherapy)
Dual Antiplatelet (DAPT) Therapy
Drug
Dual antiplatelet therapy according to guidelines

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Intervention ArmExperimental treatment 1 intervention

Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

J.P.S Henriques

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor institution

Source ClinicalTrials.gov

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