drugset / Trial / NCT05681702

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Phase 4 Recruiting 90 enrolled University of Florida
RandomizedParallel-groupOpen-labelTreatment

Summary

Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.

Timeline

Start
2023-02-15
Primary completion
2026-12-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 81 mg
Comparator Clopidogrel Small molecule 75 mg Oral
Subject Prasugrel Small molecule 10 mg Oral
Subject Ticagrelor Small molecule 90 mg Oral