Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06228456
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2024-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Pharmacodynamic Effects of Low-dose Ticagrelor vs. Clopidogrel in Stable Patients Undergoing Elective Percutaneous Coronary Intervention Who Are At Risk of Peri-PCI Myocardial Infarction Using a Precision Medicine Tool
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better pharmacodynamic effects (i.e., lower platelet reactivity and high platelet reactivity rates) compared with clopidogrel in stable coronary artery disease patients undergoing percutaneous coronary intervention with a high ABCD-GENE score.
Detailed Description:
Clopidogrel is the P2Y12 inhibitor of choice in patients with stable coronary artery disease (CAD) undergoing elective percutaneous coronary intervention (PCI). However, clopidogrel effects are subject to variability and 30-40% of patients have high platelet reactivity (HPR), which translates into higher rates of thrombotic complications. Despite the relative safety of PCI with new generation stents, peri-PCI thrombotic complications, including myocardial infarction and myocardial injury, are common in elective PCI. Importantly, these events are associated with poor prognosis, including cardiovascular mortality. The risk of peri-PCI myocardial infarction/myocardial injury has been in part attributed to HPR. A precision medicine tool integrating clinical (age, body mass index, chronic kidney disease and diabetes) and genetic (CYP2C19 loss-of-function allele status) factors called ABCD-GENE is able to identify HPR status. This score helps characterize patients at risk for peri-PCI thrombotic complications, who can thus potentially benefit from changes in antiplatelet treatment regimen. The new generation oral P2Y12 inhibitors prasugrel and ticagrelor are more potent than clopidogrel and associated with lower HPR rates and improved outcomes. Hence, these agents may be beneficial in reducing peri-PCI myocardial infarction/myocardial injury. Standard-dose ticagrelor (90 mg bid) provides more potent antiplatelet effect than clopidogrel in patients with ACS. Low-dose ticagrelor (60 mg bid) is beneficial in patients with prior myocardial infarction and has the potential of better bleeding profile compared to standard dose.This prospective randomized study aims to assess the antiplatelet effects of more potent oral P2Y12 inhibition with low-dose ticagrelor (60 mg bid) compared with standard of care clopidogrel in patients with a high ABCD-GENE score (≥10). We hypothesize that ticagrelor is associated with better PD effects (i.e., lower platelet reactivity and HPR rates) compared with clopidogrel in stable CAD patients undergoing PCI with a high ABCD-GENE score.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: