DRKS00022562招募中未知
Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke prevention - EdoxCKD
Medizinische Fakultät der Martin-Luther-Universität0 个研究点目标入组 72 人开始时间: 2020年7月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 89 Years（—）
- 性别
- All
入选标准
- •Male and female patients aged 18 - 89 years
- •- Non-valvular atrial fibrillation
- •- Indication for initiation of oral anticoagulation therapy
- •- Cockcroft-Gault CreaCl 15 ml/min or higher
- •- CHA2DS2-VASc risk score = 2 (men) or = 3 (women)
- •- hospitalisation for reasons other than mere participation in this study
- •- Body weight from =60 kg to =125 kg during screening
- •- Written informed consent
- •- For women of childbearing potential: consent to the use of highly effective contraception (Pearl Index < 1)
- •- For men: consent to the use of condom as an additional contraception
排除标准
- •- Cockcroft-Gault CreaCl < 15ml/min, unstable kidney function and/or need for renal replacement therapy
- •- Presence of a functional kidney transplant
- •- Known hypersensitivity to the active substance or to any of the excipients of the investigational medicinal product
- •- Clinically relevant, active bleeding
- •- Hepatic Disease associated with coagulopathy and clinically relevant bleeding risk
- •- Liver cirrhosis Child-Pugh stage C
- •- lesion or condition that may put the patient at significant risk for major bleeding, including but not limited to:
- •- Acute or recent (< 1 month) gastrointestinal ulceration,
- •- Malignant neoplasms at high risk of bleeding,
- •- Recent (< 1 month) brain or spinal injuries,
- •- Recent (< 1 month) brain, spinal or ophthalmic surgery,
- •- Recent (< 1 month) intracranial hemorrhage,
- •- Known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral
- •vascular abnormalities
- •- Uncontrolled, severe arterial hypertension
- •- Current use (up to 7 days before screening) of NOAC or VKA
- •- Simultaneous systemic use of heparin or its derivatives (UFH, low molecular weight heparins, Fondaparinux, etc.) except under special circumstances of switching to oral anticoagulant therapy or when UFH is
- •given at doses necessary to maintain an open central venous or arterial catheter
- •- Simultaneous systemic use of NSAIDs
- •- Pregnancy and lactation
- •- Co-treatment with one of the P-glycoprotein inhibitors Ciclosporin, Dronedarone, Erythromycin, Ketoconazole within the last 14 days, except for topical use
- •- Co-treatment with one of the P-glycoprotein inducers Apalutamid, Carbamazepin, Enzalutamid, Johanniskraut, Letermovir, Phenobarbital, Phenytoin, Pitolisant, Rifampicin within the last 14 days
- •- Inability to understand study procedures and to give informed consent
- •- Persons who due to judicial or administrative arrangement are housed in an institution
- •- Simultaneous participation in another interventional study
研究者
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