Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Recruiting now · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT05681702

Run by

University of Florida

People needed

90

Starts

2023-02-15

Expected to finish

2027-03-31

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients who presented with chronic coronary syndrome, 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 days. Or patients that presented with an Acute coronary syndrome (ACS) event and underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10mg od) or ticagrelor (90mg bid) for 3 months or greater.
• Age ≥18 years old
• Provide written informed consent

You may not qualify if…

• Prior history of stent thrombosis
• On 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 dialysis
• Patients with known bleeding diathesis or coagulation disorders
• Known severe hepatic impairment
• Hemodynamic instability
• Hypersensitivity to clopidogrel
• Pregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study]

Where it is running

• University of Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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