drugset / Trial / NCT04483583

Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI

NCT04483583 ↗

Phase 4 Completed 81 enrolled University of Florida
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-12-08
Primary completion
2025-01-07
Completion
2025-01-07

Outcome

Met primary endpoint

paper At 30 days, PRU levels were reduced with ticagrelor-based DAT compared with clopidogrel-based DAT at trough (23.0 [Q1-Q3: 3.0-46.0] vs 154.5 [Q1-Q3: PMID 38597172 ↗

paper 77.5-183.0]; P < 0.001) PMID 38597172 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clopidogrel Small molecule 75 mg —
Subject Ticagrelor Small molecule 60 mg —