NCT02539953撤回不适用
Ambulatory Blood Pressure Monitoring in Rivaroxaban Therapy
King's College Hospital NHS Trust1 个研究点 分布在 1 个国家开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Average blood pressure readings
研究概览
简要总结
One in ten patients on rivaroxaban therapy have dizziness and reductions in blood pressure. The investigators intend to monitor the ambulatory blood pressure of such patients in order to assess whether this is a true haemodynamic effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years
- •Able to provide written, informed consent
- •Taking rivaroxaban for any indication within the license of the drug, both once daily and twice daily dosing can be included
- •Have measurable rivaroxaban levels on at least one occasion (this will be in line with standard of care, there will be no extra blood samples for the study)
- •Not taking concomitant medication that can affect rivaroxaban metabolism (including amiodarone, dronedarone, -azole antifungals, protease inhibitors)
- •On no antihypertensive or vasoactive medication
- •Have a baseline BP recording taken in clinic
排除标准
- •Unable to provide written, informed consent
- •Presence of concomitant medication that may alter rivaroxaban levels and confound results (see above)
- •Unwilling to undergo ambulatory blood pressure monitoring
- •Contraindication to ambulatory blood pressure monitoring
结局指标
主要结局
Average blood pressure readings
时间窗: 48 hours
次要结局
- Correlation of blood pressure readings to rivaroxaban dosing(48 hours)
- Correlation of blood pressure readings to symptomatology(48 hours)
研究者
研究点 (1)
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