Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors
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
University of Florida
48 participants
Jan 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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.
- Age between 18 and 75 years old
- Able to provide written informed consent
Exclusion Criteria11
- Prior history of stent thrombosis
- PCI within 90 days.
- History of stroke/TIA
- Age > 75 years old
- Weight < 60 kg
- History of intracranial hemorrhage
- On treatment with any oral anticoagulant or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
- Patients with known coagulation disorders
- Known severe hepatic impairment
- Hypersensitivity to prasugrel or ticagrelor
- 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.
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Interventions
After providing written informed consent, patients on DAPT meeting study entry criteria will stop aspirin and be randomly assigned in a 1:1 fashion using a computer-based randomization system to either: a) ticagrelor 90 mg bid monotherapy or b) prasugrel 10 mg qd monotherapy. Patients will continue the randomized treatment for 21±7 days.
After providing written informed consent, patients on DAPT meeting study entry criteria will stop aspirin and be randomly assigned in a 1:1 fashion using a computer-based randomization system to either: a) ticagrelor 90 mg bid monotherapy or b) prasugrel 10 mg qd monotherapy. Patients will continue the randomized treatment for 21±7 days.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06691191