Status:
COMPLETED
Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI
Lead Sponsor:
University of Florida
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Clopidogrel is the P2Y12 inhibitor of choice in PCI patients requiring OAC. However, concerns have been raised based on the notion that a considerable number of patients may have inadequate response t...
Detailed Description
The combination of aspirin plus a P2Y12 receptor inhibitor, also known as dual antiplatelet therapy (DAPT), is the cornerstone of treatment for patients with coronary artery disease (CAD) undergoing p...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥ 18 years
- Willing and able to provide written informed consent
- Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care
- On treatment with a novel oral anticoagulant (apixaban, dabigatran, edoxaban, or rivaroxaban) for any indication (dosing regimen will be according to standard of care and at the discretion of the treating physician)
- Exclusion criteria:
- Any active bleeding or history of major bleeding
- Ischemic Stroke within 1 month
- Any history of hemorrhagic stroke, or intracranial hemorrhage
- Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions.
- End-stage renal disease on hemodialysis
- Known severe liver dysfunction or any known hepatic disease associated with coagulopathy
- History of hypersensitivity or known contraindication to clopidogrel or ticagrelor.
- Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus \[HIV\]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e.
- rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
- Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control (e.g. surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization)
- Concomitant participation in another study with investigational drug
- Hemoglobin ≤9 mg/dL
- Platelet count \<80x106/mL
Exclusion
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04483583
Start Date
December 8 2020
End Date
January 7 2025
Last Update
July 31 2025
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209