Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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 to clopidogrel. Although practice recommendations indicate that the use of potent P2Y12 inhibitors (i.e., ticagrelor) may be considered in patients at increased thrombotic risk, they do not recommend routine testing to identify patients with poor response to clopidogrel. The aim of this study is to assess the pharmacodynamic effects of different P2Y12 inhibiting therapy (clopidogrel vs ticagrelor) in patients at high risk for high platelet reactivity identified according to the ABCD-GENE score in PCI treated patients also requiring OAC. Up to a total of up to 63 patients are planned to be prospectively enrolled in this investigation which will entail a series of comprehensive pharmacodynamic assessments to reach the study aim.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Clopidogrel; Ticagrelor

Criteria

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 or lacunar 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