NL-OMON52027招募中4 期
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 Florida College of Medicine0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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)
排除标准
- •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
研究者
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