2023-507544-37-00招募中3 期
Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 19
- 主要终点
- Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).
研究概览
简要总结
To compare the safety of apixaban versus warfarin, comparing the incidence of the endpoint Bleeding
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 ≥
- •For women of childbearing age and sexually active, use of an effective method of contraception
- •Signing of informed consent
- •Affiliation to a social security scheme
排除标准
- •Patients not considered candidates for oral anticoagulation (active bleeding, recent gastrointestinal bleeding, severe hepatic impairment)
- •History of anaphylactic reaction to apixaban
- •Use of millepertuis (potent CYP3A4 inducer).
- •Use of powerful inhibitors of CYP3A4 and gp-P: o azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, miconazole - systemic route and oral gel) o HIV protease inhibitors.
- •Taking acetylsalicylic acid in doses of 500 mg per dose to 3 g per day
- •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)
结局指标
主要结局
Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).
Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).
次要结局
- Stroke or systemic embolism [Period: From randomization until Month 12].
- Myocardial infarction [Period: From randomization until Month 12].
- Death from any cause [Period: From randomization until Month 12].
- INR values, interpretation by Rosendaal method
- antiXa activity of apixaban at M1, M6, M12, and in case of bleeding.
研究者
coordinator
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (19)
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