Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI (TAILOR BLEED)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Dual antiplatelet therapy, Bleeding
Eligibility Criteria
Inclusion Criteria: Patients who presented with chronic coronary syndrome, underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10 mg od) or ticagrelor (90 mg bid) for at least 30 days. Or patients that presented with an Acute coronary syndrome (ACS) event and underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10mg od) or ticagrelor (90mg bid) for 3 months or greater. Age ≥18 years old Provide written informed consent Exclusion Criteria: Prior history of stent thrombosis On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis) Renal failure requiring dialysis Patients with known bleeding diathesis or coagulation disorders Known severe hepatic impairment Hemodynamic instability Hypersensitivity to clopidogrel Pregnant and breastfeeding women [women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study]
Sites / Locations
- University of FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
DAPT de-escalation
Potent P2Y12 monotherapy
Aspirin 81-mg od and clopidogrel 75-mg qd.
Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.