EUCTR2019-003100-13-DE进行中（未招募）1 期
Pharmacokinetics of edoxaban in patients with advanced chronic kidney disease (CKD) treated for stroke prevention - EdoxCKD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 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
- •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 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
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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