RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Ticagrelor 90 mg

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.

DRUG

Prasugrel 10 mg

Locations (1)

University of Florida Jacksonville

Jacksonville, Florida, United States