Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Conditions
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.
Interventions
DRUGPrasugrel 5 mg
Prasugrel 5 mg once daily (monotherapy)
Dual antiplatelet therapy according to guidelines
Sponsors
J.P.S Henriques
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NACE (Net Adverse Clinical Events) | 12 months | 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 |
Countries
Netherlands
Outcome results
None listed