2024-519737-30-00招募中4 期
Weight-loss Effects aNd absorption of Direct oral anticoagulants in roux-en-Y gastric bypass patients: a prospective study (WENDY)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC) of anti-Xa levels comparing at multiple timepoints: baseline (prior to surgery), +/-17 days untill 60days after surgery, +/-3 months after surgery
研究概览
简要总结
To assess the difference in the pharmacokinetics of apixaban before and after RYGB
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Prospective cohort study
- 盲法
- None
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
- •Patients who are screened and approved to undergo laparoscopic ggastric bypass
- •Age 18 years or older
排除标准
- •Symptomatic thrombos at inclusion
- •Use of antiplatelet agent or chronic use of NSAID
- •Known allergy to apixaban
- •Inadequate or lack of contraceptive methods by the patient when relevant
- •Inability to adhere to treatment or to the follow-up visits
- •Current use of anticoagulant medication, such as apixaban, rivaroxaban, edoxaban, dabigatran, acenocoumarol, fenprocoumon, low molecular weighted heparin or heparin
- •Major bleeding defined according to the International Society on Thrombosis and Haemostasis in the 6 months prior to start participation
- •Liver cirrhosis
- •Severe renal insufficiency (eGFR <30 ml/min/1.73 m2)
- •Concurrent use of strong inhibitors or inducers of cytochrome P450 or P-glycoprotein
- •Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than six months, or unwillingness to sign informed consent
- •Known bleeding diathesis or bleeding disorder
结局指标
主要结局
Area under the curve (AUC) of anti-Xa levels comparing at multiple timepoints: baseline (prior to surgery), +/-17 days untill 60days after surgery, +/-3 months after surgery
Area under the curve (AUC) of anti-Xa levels comparing at multiple timepoints: baseline (prior to surgery), +/-17 days untill 60days after surgery, +/-3 months after surgery
次要结局
- Measured weight and BMI at follow-up visit +3 months in relation to AUC anti-Xa difference
- Frequence of major bleeding events as defined per ISTH criteria, and incidence of VTE, including pulmonary embolism and deep vein thrombosis
研究者
Dr. M. Coppens
Scientific
Amsterdam UMC Stichting
研究点 (1)
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