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
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.
Description
A strategy of P2Y12 monotherapy after 1-3 months of dual antiplatelet therapy (DAPT) is associated with a substantial reduction in bleeding events without an increase in atherothrombotic events, including in patients with acute coronary syndrome (ACS). However, different P2Y12 inhibitors vary in safety and efficacy profiles in the setting of single antiplatelet therapy (SAPT). In the TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus-eluting Stent for Acute Coronary Syndrome) trial, DAPT discontinuation at 3 months with transition to ticagrelor mo…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugTicagrelor 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.
- DrugPrasugrel 10 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.
Location
- University of Florida JacksonvilleJacksonville, Florida