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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual risk - Clopidogrel-based DAPT | Experimental | Patients deemed at high risk for both bleeding and ischemic risk randomized to continue clopdiogrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher. |
|
| Dual risk - Low-dose prasugrel-based DAPT | Experimental | Patients deemed at high risk for both bleeding and ischemic risk randomized to receive low-dose prasugrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher. |
|
| Control | Active Comparator | Patients deemed at high risk for both bleeding but not at high risk for ischemic events being actively treated with clopidogrel-based DAPT as per standard of care. High bleeding riks will be defined according to the Academic Research Consortium definition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prasugrel | Drug | Prasugrel 5 mg od for 30 ± 5 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Ortega-Paz, MD, PhD | Contact | 904-244 2060 | Luis.Ortega@jax.ufl.edu | |
| Andrea Burton, MPH, CCRP | Contact | 904-244-5617 | Andrea.Burton@jax.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dominick J Angiolillo, MD, PhD | University of Florida College of Medicine - Jacksonville | Study Chair |
| Luis Ortega-Paz, MD, PhD | University of Florida College of Medicine - Jacksonville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health | Recruiting | Jacksonville | Florida | 32209 | United States |
Individual patient data will be shared upon reasonable request to the primary investigator.
Individual patient data will be shared upon reasonable request to the primary investigator after publication of the primary results.
Individual patient data will be shared upon reasonable request to the primary investigator.
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| Clopidogrel |
| Drug |
Clopidogrel 75 mg od for 30 ± 5 days |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D011725 | Pyridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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