Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Coronary artery disease, Dual antiplatelet therapy, High bleeding risk
Brief summary
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.
Interventions
DRUGPrasugrel
Prasugrel 5 mg od for 30 ± 5 days
DRUGClopidogrel
Clopidogrel 75 mg od for 30 ± 5 days
Sponsors
University of Florida
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
* 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.
Exclusion criteria
* 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). * Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel. * Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL). * Known hemoglobinopathies or anemia (hemoglobin \<9 g/dL) * Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Platelet reactivity measured as PRU | 30 Day | 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) |
Countries
United States
Contacts
Primary ContactLuis Ortega-Paz, MD, PhD
Backup ContactAndrea Burton, MPH, CCRP
Outcome results
None listed