RECRUITING

Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors

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Conditions

Coronary Artery Diseasepercutaneous coronary interventionticagrelorprasugrelbleedingplatelets

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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

Ticagrelor currently represents the most tested and commonly used P2Y12 inhibitor monotherapy following percutaneous coronary intervention. The purpose of this study is to conduct a head-to-head comparison on the pharmacodynamic efficacy of ticagrelor-based and prasugrel-based single antiplatelet therapy. To determine if the PD profiles of ticagrelor- and prasugrel-based SAPT are comparable, we aim to conduct a non-inferiority study between the two strategies.

Official Title

Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors: Pharmadodynamic Comparison Between Prasugrel and Ticagrelor Monotherapy. The Switching Antiplatelet -7 (SWAP-7) Study

Quick Facts

Study Start:2025-01-08
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06691191

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 to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients on DAPT with aspirin plus prasugrel 10 mg or ticagrelor 90 mg bid as per standard of care at least 90 days after PCI.
  2. 2. Age between 18 and 75 years old
  3. 3. Able to provide written informed consent
  1. 1. Prior history of stent thrombosis
  2. 2. PCI within 90 days.
  3. 3. History of stroke/TIA
  4. 4. Age \> 75 years old
  5. 5. Weight \< 60 kg
  6. 6. History of intracranial hemorrhage
  7. 7. On treatment with any oral anticoagulant or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
  8. 8. Patients with known coagulation disorders
  9. 9. Known severe hepatic impairment
  10. 10. Hypersensitivity to prasugrel or ticagrelor
  11. 11. Pregnant and breastfeeding persons \[persons of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\]. If the potential subject is a person of childbearing potential, a pregnancy test will be done. If the subject is pregnant, participation in this study will end.

Contacts and Locations

Study Contact

Francesco Franchi, MD
CONTACT
9042445515
francesco.franchi@jax.ufl.edu
Andrea Burton
CONTACT
(904) 244-5617
andrea.burton@jax.ufl.edu

Principal Investigator

Francesco Franchi, MD
PRINCIPAL_INVESTIGATOR
University of Florida College of Medicine Jacksonville

Study Locations (Sites)

University of Florida Jacksonville
Jacksonville, Florida, 32209
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Francesco Franchi, MD, 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 Date2025-01-08
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2025-01-08
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • percutaneous coronary intervention
  • ticagrelor
  • prasugrel
  • bleeding
  • platelets

Additional Relevant MeSH Terms

  • Coronary Artery Disease