A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- median inhibition of factor xa inhibition
研究概览
简要总结
The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied.
The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups
- Non obese people who have not had a gastric bypass.
- Obese people who have not had a gastric bypass
- People who have had a gastric bypass
- People who are planning to undergo gastric bypass surgery in the near future who are willing to be studied before and after the bypass.
The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Healthy volunteers in one of four groups
- •Normal weight and not having prior gastric bypass surgery,
- •Obese and not having prior gastric bypass surgery,
- •Subjects with prior roux en Y gastric bypass surgery,
- •Obese and planning to undergo roux en Y gastric bypass
排除标准
- •Active renal or liver disease,
- •bleeding diathesis,
- •concurrent treatment with anticoagulants or aspirin,
- •indication for aspirin or anticoagulant treatment,
- •gastrointestinal bleeding,
- •uncontrolled hypertension,
- •active malignancy,
- •thrombocytopenia,
- •pregnant,
- •allergy to rivaroxaban,
- •coagulopathy or any other medical condition that would increase risk to the subject
研究组 & 干预措施
normal subjects
A single dose of 10 mg of rivaroxaban will be administered
干预措施: rivaroxaban (Drug)
Obese non bypassed
A single dose of rivaroxaban will be administered
干预措施: rivaroxaban (Drug)
obese bypassed
A single dose of rivaroxaban will be administered
干预措施: rivaroxaban (Drug)
pre and post bypassed subject
A single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass
干预措施: rivaroxaban (Drug)
结局指标
主要结局
median inhibition of factor xa inhibition
时间窗: 24 hours
pharmacodynamic
次要结局
- median prolongation of prothrombin time(24 hours)