Prospective Randomized Controlled, Open Label, Clinical Trial to Study if Rosuvastatin Use Improves the Coagulation Profile in Patients With Venous Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 3
- 主要终点
- Coagulation factor VIII
研究概览
简要总结
Epidemiological studies have shown a 2-3 fold increased long-term risk of arterial cardiovascular disease after venous thrombosis, most predominant in the first year following initial venous thrombosis. The results of recent observational studies that showed 40-50% risk reductions for first venous thrombosis occurrence when using a statin are in this aspect promising. The results are also somewhat surprising, because the mechanism behind this effect is unclear. Dyslipidemia may be the most plausible explanation to be considered. However, as dyslipidemia is not related to an increased risk of venous thrombosis, it is unlikely that statins decrease venous thrombosis risk by lipid lowering activities. Recent observations indicate that coagulation can activate the initial formation of atherosclerosis. Our hypothesis is therefore that the coagulation profile in persons with venous thrombosis is improved when using a statin, ultimately leading to less atherosclerosis: another well known property of statin use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Provision of informed consent prior to any study specific procedures
- •Persons with (initial or recurrent) confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who after a time period of at least 3 to 12 months are allowed to stop, - or stopped using < 1 month anticoagulant treatment as indicated by their treating physician
- •Persons aged 18 years or above
排除标准
- •Persons already using statins or lipid lowering drugs, or any other disallowed concomitant medications (erythromycin, HIV protease inhibitors, or cyclosporine)
- •History of statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
- •Life expectancy less than 6 months
- •Pregnant woman or woman with childbearing potential who are not willing to use contraception
- •Active liver or kidney disease or dysfunction or muscle disorders
- •Unstable medical or psychological condition that interferes with study participation
研究组 & 干预措施
Rosuvastatin
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Coagulation factor VIII
时间窗: 28 days
Change in factor VIII level from baseline to 28 days of intervention
次要结局
未报告次要终点
研究者
Willem M. Lijfering
Principal Investigator
Leiden University Medical Center
