Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

RECRUITING

NCT05681702

PHASE4

Sponsor: University of Florida

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.

Official title: Tailoring Bleeding Reduction Approaches in Patients Undergoing Percutaneous Coronary Interventions: Comparative Pharmacodynamic Effects of Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy De-escalation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2023-02-15

Completion Date

2027-03-31

Last Updated

2026-03-09

Healthy Volunteers

Yes

Conditions

Coronary Artery Disease

Interventions

DRUG

aspirin plus clopidogrel

After at least 30 days of DAPT \[with aspirin 81-mg od and a potent P2Y12 inhibitor (prasugrel 10 mg od or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will continue aspirin and switch to clopidogrel 75-mg.

DRUG

prasugrel or ticagrelor

After at least 30 days of DAPT \[with aspirin 81-mg od and a potent P2Y12 inhibitor (prasugrel 10 mg od or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will drop aspirin and continue prasugrel or ticagrelor.

Locations (1)

University of Florida

Jacksonville, Florida, United States

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