Tailoring P2Y12 Inhibiting Therapy in Patients requiring Oral Anticoagulation after undergoing Percutaneous Coronary Intervention: The Switching Anti-Platelet and Anti-Coagulant Therapy – 2 Study - SWAP-AC-2 study

niversity of Florida0 个研究点目标入组 84 人开始时间: 2021年6月24日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•Age = 18 years
•Willing and able to provide written informed consent
•Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care
•On treatment with a novel oral anticoagulant (apixaban, dabigatran, edoxaban, or rivaroxaban) for any indication (dosing regimen will be according to standard of care and at the discretion of the treating physician)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 74

•Any active bleeding or history of major bleeding
•Ischemic Stroke within 1 month
•Any history of hemorrhagic or lacunar stroke, or intracranial hemorrhage
•Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic
•cancer) or that increases the risk of an adverse reaction to study interventions.
•End-stage renal disease on hemodialysis
•Known severe liver dysfunction or any known hepatic disease associated with coagulopathy
•History of hypersensitivity or known contraindication to clopidogrel or ticagrelor.
•Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (e.g.,
•systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus
•[HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e.
•rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
•Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually
•active and not practicing an effective method of birth control (e.g. surgically sterile,
•prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization)
•Concomitant participation in another study with investigational drug
•Hemoglobin =9 mg/dL
•Platelet count <80x106/mL

发起方

niversity of Florida