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临床试验/CTIS2023-507544-37-00
CTIS2023-507544-37-00进行中(未招募)1 期

Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial - 23-0164 (APIDP2)

Centre Hospitalier Universitaire De Caen Normandie0 个研究点目标入组 178 人开始时间: 2024年2月19日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
178

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Men and women, aged at least 18 years, with end-stage renal disease (ESRD) treated with peritoneal dialysis for = 3 months., Patients with a history of non-valvular atrial fibrillation treated with oral anticoagulation or patients starting oral anticoagulation for a diagnosis of non-valvular atrial fibrillation, CHA2DS2-VASc score = 2., For women of childbearing age and sexually active, use of an effective method of contraception, Signing of informed consent

排除标准

  • Patients not considered candidates for oral anticoagulation (e.g., hemoglobin < 8.5 g/dL, history of intracranial hemorrhage, active bleeding, recent gastrointestinal bleeding or retroperitoneal bleeding, severe hepatic impairment, or anaphylactic reaction to apixaban), Patient with history of TIA or stroke in the 3 months preceding inclusion, Patient treated with hemodialysis (hybrid dialysis), Moderate or severe mitral stenosis, Conditions other than non-valvular atrial fibrillation requiring anticoagulation, such as mechanical prosthetic valves, anti-phospholipid syndrome, Life expectancy less than 3 months, Registration on the waiting list for a kidney transplant with a cadaveric donor, Pregnant or breastfeeding woman, Patient under legal protection (Curatelle-Tutelle – Protection of justice)

研究者

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