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Not Yet Recruiting NCT05681702

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Conditions: Coronary Artery Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 90
Sponsor: University of Florida

Location: United States

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.

Eligibility Criteria

Inclusion Criteria:Patients who underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10 mg od) or ticagrelor (90 mg bid) for at least 30 daysAge ≥18 years oldProvide written informed consentExclusion Criteria:Prior history of stent thrombosisOn treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)Renal failure requiring dialysisPatients with known bleeding diathesis or coagulation disordersKnown severe hepatic impairmentHemodynamic instabilityHypersensitivity to clopidogrelPregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study]

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05681702). StuddyBuddy aggregates publicly available trial information.