EUCTR2020-005110-17-IT进行中（未招募）1 期
Pharmacodynamic and pleiotropic effects of Rivaroxaban in Coronary Artery Disease and Atrial Fibrillation - PhRisCo-study
AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA0 个研究点目标入组 45 人开始时间: 2021年6月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In group A and C will be included patients without AF and with stable CAD (previous MI > 1 year), and at least one of the following additional factors:
- •¿ PAD (Peripheral Artery Disease)
- •¿ Diabetes mellitus (DM)
- •¿ Chronic kidney disease (CKD)
- •Group B will comprise patients with AF and stable CAD (previous MI > 1 year), and at least one of the following additional factors:
- •¿ PAD (Peripheral Artery Disease)
- •¿ Diabetes mellitus (DM)
- •¿ Chronic kidney disease (CKD)
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •¿ Known hypersensitivity to the active substance or any of the excipients.
- •¿ Active clinically significant bleeding.
- •¿ Injuries or conditions that constitute a significant risk of major bleeding (these may include recent or ongoing gastric ulceration, presence of malignant neoplasms at high risk of bleeding, recent cerebral or spinal traumatism, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities).
- •¿ Concomitant treatment with other anticoagulants, such as unfractionated heparins, low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.) or chronic oral anticoagulant therapy.
- •¿ Previous hemorrhagic or lacunar stroke, or any stroke within 1 month.
- •¿ Hepatic disease associated with coagulopathy and clinically-relevant bleeding risk, including cirrhotic patients with Child Pugh B and C.
- •¿ Creatinine clearance <30 mL / min (estimated)
- •¿ Pregnancy and breast-feeding.
研究者
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