Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Tmax of rivaroxaban
研究概览
简要总结
Aim of this clinical Trial is the assessment of rivaroxaban PK/PD parameters in patients 6-8 months after bariatric surgery
详细描述
Weight loss after bariatric surgery can putatively alter drug disposition of rivaroxaban. This may be due to an altered intestinal adaptations several months after the surgical procedure. The aim of this clinical trial is to investigate pharmacokinetic and pharmacodynamic parameters after single application of 10 mg rivaroxaban in patients with prior bariatric intervention (Roux-en-y-gastric bypass or sleeve gastrectomy 6-8 months ago). PK/PD parameters will be assessed during 12 hours after application of rivaroxaban.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with past elective bariatric surgery (Roux-en-Y gastric bypass surgery or sleeve gastrectomy 6-8 months ago)
- •Patient aged 18 years and older
- •BMI ≥ 35 kg/m2
- •Women of child-bearing age: Willingness of using a double barrier contraception method during the study
- •Written, informed consent
排除标准
- •Intake of oral anticoagulants (phenprocoumon, acenocoumarol, dabigatran, etexilate, apixaban etc.) 4 weeks prior to inclusion in the study
- •Application of parenteral anticoagulants (unfractionated heparin, low molecular weight heparins, heparin derivates (fondaparinux etc.) 4 weeks prior to inclusion in the study
- •Pharmacologic platelet inhibition 4 weeks prior to inclusion in the study
- •Known coagulation disorders (e.g. Willebrand's disease, haemophilia)
- •Evidence for deep vein thrombosis or pulmonary embolism in the personal history or in the history of first degree relatives
- •Medical condition that is associated with an increased risk for VTE, i.e. active cancer disease, lupus erythematodes chronic inflammatory bowel disease
- •Active, clinically significant bleeding
- •Congenital or acquired bleeding disorder
- •Uncontrolled severe hypertension
- •Active gastrointestinal disease that can potentially lead to bleeding disorder: oesophagitis, gastritis, gastroesophageal reflux disease, chronic inflammatory bowel disease
- •Vascular retinopathy
- •Bronchiectasis or history of pulmonary bleeding
- •Prior stroke or TIA
- •Hereditary galactose intolerance, Lapp lactase deficiency, glucose-lactose malabsorption
- •Severe renal impairment with a creatinine clearance (GFR) of < 30ml/min
- •Positive pregnancy test, pregnancy or nursing women
- •High risk of bleeding (e.g. active ulcerative gastrointestinal disease)
- •Known intolerance of the study medication rivaroxaban
- •Concomitant treatment with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, lopinavir, ritonavir, indinavir)
- •Concomitant treatment with an P-glycoprotein inhibitor and weak or moderate CYP3A4 inhibitor (e.g. erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine)
研究组 & 干预措施
Rivaroxaban Arm
干预措施: Rivaroxaban 10 mg (Drug)
结局指标
主要结局
Tmax of rivaroxaban
时间窗: 1 year
Prothrombin time (PT)
时间窗: 1 year
AUC of rivaroxaban
时间窗: 1 year
Cmax of rivaroxaban
时间窗: 1 year
Activated partial thromboplastin time (aPTT)
时间窗: 1 year
Levels of Prothrombin fragment (F1+F2)
时间窗: 1 year
Levels of Thrombin-antithrombin-complexes (TAT)
时间窗: 1 year
Levels of D-Dimers
时间窗: 1 year
次要结局
未报告次要终点