EUCTR2018-000484-86-DK进行中（未招募）1 期
DAN-WAR-DDanish Warfarin-Dialysis StudySafety and efficacy of warfarin in patients with atrial fibrillation on dialysis -A nationwide parallel-group open randomized clinical trial - DAN-WAR-D - Danish Warfarin-Dialysis Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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
- •1. Patients =18 years on chronic dialysis due to end-stage renal disease with de novo diagnosis of non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for >2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of =30 seconds on Holter monitor, or episodes = 6 minutes on event recorders or any other recording device.
- •2. Competence to understand the study rational, including potential risks and benefits associated with treatment, necessary for 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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •1. CHA2DS2-VASc Score =1
- •2. Other indications for oral anticoagulation treatment (pulmonary embolism < 6months, deep vein thrombosis
- •<3months, prior atrial fibrillation, mechanical heart valve prosthesis) - irrespective of whether treatment is
- •implemented
- •3. Ongoing dual antiplatelet treatment
- •4. Malignancy (with exception of non-melanoma skin cancer) with recent < 1 year, ongoing, or planned curative,
- •or palliative chemo- , radiation-, and/or scheduled surgical therapy
- •5. Endoscopy with gastrointestinal ulcer <1 month
- •6. Esophageal varices
- •7. Autuimmune og genetic coagulation disorders
- •8. Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption
- •9. Pending spinal tap
- •10. Cerebrovascular malformations
- •11. Arterial aneurisms
- •12. Ulcers or wounds (Wagner grad >1)
- •13. Bacterial endocarditis < 3 months
- •14. Active bleeding contraindicating anticoagulation
- •15. Any non-elective and/or non-ambulant surgery <7 days
- •16. Cerebral hemorrhage <4 weeks
- •17. Thrombocytopenia (platelet count <100 × 109/L) <30 days.
- •18. Severe liver insufficiency (spontaneous international normalized ratio >1.5) <30 days.
- •19. Known intolerance to warfarin
- •20. Use of hypericum perforatum / St. John’s Wort
- •21. Uncontrolled hypertension (repeat blood pressure >180/110mmhg) < 30 days
- •22. Uncontrolled hyperthyroidism (thyroid-stimulating hormone <0.1µIU/mL) <30 days
- •23. Pregnancy or lactation
- •24. Participation in other ongoing intervention trials adjudged to influence study outcomes
研究者
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