Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
NCT05681702

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Led by University of Florida · Updated on 2026-03-09

90

Participants Needed

1

Research Sites

215 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic coronary syndrome who underwent PCI and have been on dual antiplatelet therapy with low-dose aspirin and prasugrel or ticagrelor for at least 30 days
  • Patients with acute coronary syndrome who underwent PCI and have been on dual antiplatelet therapy with low-dose aspirin and prasugrel or ticagrelor for at least 3 months
  • Age 18 years or older
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Prior history of stent thrombosis
  • Currently treated with any oral anticoagulant or chronic low-molecular-weight heparin for venous thrombosis treatment
  • Renal failure requiring dialysis
  • Known bleeding disorders or coagulation problems
  • Severe liver impairment
  • Hemodynamic instability
  • Allergy or hypersensitivity to clopidogrel
  • Pregnant or breastfeeding women (women of childbearing age must use reliable birth control during the study)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Florida

Jacksonville, Florida, United States, 32209

Actively Recruiting

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Research Team

D

Dominick J Angiolillo, MD,PhD

CONTACT

A

Andrea Burton, MPH, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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