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Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

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

Who can join

Ages 18 and older · All sexes · Healthy volunteers welcome

Inclusion Criteria:

1. 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.
2. Age ≥18 years old
3. Provide written informed consent

Exclusion Criteria:

1. Prior history of stent thrombosis
2. 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)
3. Renal failure requiring dialysis
4. Patients with known bleeding diathesis or coagulation disorders
5. Known severe hepatic impairment
6. Hemodynamic instability
7. Hypersensitivity to clopidogrel
8. Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\]

About the study

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.

What is being tested

• aspirin plus clopidogrel (drug)
• prasugrel or ticagrelor (drug)

Sponsor: University of Florida · Participants: 90 · Started: Feb 15, 2023

Contact the study team

• Dominick J Angiolillo, MD,PhD · Phone: +1-904-244-3378
• Andrea Burton, MPH, CCRP · Phone: +1-904-244-5617

Official record on ClinicalTrials.gov — NCT05681702

Locations in the U.S.

Conditions

• Coronary Artery Disease
• Bleeding

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.