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Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors

RECRUITINGPhase 4Sponsored by University of Florida
Actively Recruiting
PhasePhase 4
SponsorUniversity of Florida
Started2025-01-08
Est. completion2026-08-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion criteria:

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. Age between 18 and 75 years old
3. Able to provide written informed consent

Exclusion criteria:

1. Prior history of stent thrombosis
2. PCI within 90 days.
3. History of stroke/TIA
4. Age \> 75 years old
5. Weight \< 60 kg
6. History of intracranial hemorrhage
7. On treatment with any oral anticoagulant or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
8. Patients with known coagulation disorders
9. Known severe hepatic impairment
10. Hypersensitivity to prasugrel or ticagrelor
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.

Conditions2

Coronary Artery DiseaseHeart Disease

Locations1 site

University of Florida Jacksonville
Jacksonville, Florida, 32209
Francesco Franchi, MD

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