Skip to content
Bored Studies
RecruitingAccepts healthy volunteersPhase 4

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

University of Florida · NCT05681702

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
90
US sites recruiting
1
Study start
February 15, 2023
Record last updated
March 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: aspirin plus clopidogrel; prasugrel or ticagrelor

Conditions: Coronary Artery Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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]

Recruiting US locations

  • University of Florida

    Jacksonville, FL 32209

    Site contact: Dominick J Angiolillo, MD, PhD · dominick.angiolillo@jax.ufl.edu

Study contacts (from the official record)

  • Dominick J Angiolillo, MD,PhD · +1-904-244-3378 · dominick.angiolillo@jax.ufl.edu
  • Andrea Burton, MPH, CCRP · +1-904-244-5617 · Andrea.Burton@jax.ufl.edu
All heart & blood pressure studies in Florida →
Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI (NCT05681702) | Bored Studies