EUCTR2004-002888-24-DE进行中（未招募）不适用
An open-label, multi-center trial to evaluate the feasibility and safety of short-term treatment with subcutaneously injected certoparin (8000 U anti-Xa twice daily) in patients with persistent nonvalvular atrial fibrillation - AFFECT
ovartis Pharma GmbH0 个研究点开始时间: 2005年9月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •women or men =18 years
- •persistent AF (electrical cardioversion is planned)
- •written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •unsuccessful cardioversion in the past
- •UFH or LMWH for more than 48 hours before start of study drug
- •current oral anticoagulation
- •indication for medical cardioversion
- •acute clinical signs of venous thromboembolism
- •platelet count <100000/µL
- •body weight <60 kg
- •known hypersensitivity to certoparin or heparin
- •recent (within the last 3 months) or active bleeding
- •acute (or suspicion of) stroke, intracranial bleeding or cerebral aneurysm
- •severe uncontrolled hypertension
- •known severe hepatic or renal insufficiency or serum creatinine >2 mg/dL
- •known pregnancy or breastfeeding or women of childbearing potential without reliable contraception
- •participation in another investigative drug study within the last 30 days
研究者
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