RECRUITING

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-02-15
Study Completion:2025-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05681702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Age ≥18 years old
  3. 3. Provide written informed consent
  1. 1. Prior history of stent thrombosis
  2. 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. 3. Renal failure requiring dialysis
  4. 4. Patients with known bleeding diathesis or coagulation disorders
  5. 5. Known severe hepatic impairment
  6. 6. Hemodynamic instability
  7. 7. Hypersensitivity to clopidogrel
  8. 8. Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\]

Contacts and Locations

Study Contact

Dominick J Angiolillo, MD,PhD
CONTACT
+1-904-244-3378
dominick.angiolillo@jax.ufl.edu
Andrea Burton, MPH, CCRP
CONTACT
+1-904-244-5617
Andrea.Burton@jax.ufl.edu

Principal Investigator

Dominick J Angiolillo, MD,PhD
PRINCIPAL_INVESTIGATOR
University of Florida College of Medicine Jacksonville

Study Locations (Sites)

University of Florida
Jacksonville, Florida, 32209
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Dominick J Angiolillo, MD,PhD, PRINCIPAL_INVESTIGATOR, University of Florida College of Medicine Jacksonville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2025-04-15

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2025-04-15

Terms related to this study

Keywords Provided by Researchers

  • Percutaneous coronary intervention
  • Dual antiplatelet therapy
  • Bleeding

Additional Relevant MeSH Terms

  • Coronary Artery Disease