About this trial
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with high bleeding risk (defined according to the ARC-HBR criteria) who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin (81mg qd) with clopidogrel (75 mg qd) as part of standard of care for at least 30 days.
Age ≥18 years.
Provide written informed consent.
Disqualifiers
Prior cerebrovascular event.
PCI within 30 days.
Hemodynamic instability.
On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis).
Trial design
Parallel
Treatments tested in this trial
Prasugrel
DrugPrasugrel 5 mg od for 30 ± 5 days
Clopidogrel
DrugClopidogrel 75 mg od for 30 ± 5 days
Treatment groups
Trial outcomes
Primary outcomes
Platelet reactivity measured as PRU
The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system in patients at dual-risk (both HBR and HIR \[ABCD-GENE score ≥10 points\]) between low-dose prasugrel (5 mg qd) vs. standard-dose clopidogrel (75 mg qd)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.