NCT01164540撤回3 期
A Randomised, Double-blind, Placebo-controlled, Event Driven, Phase III Study of Rosuvastatin 20 mg Once Daily in the Long Term Prevention of Recurrent Venous Thromboembolism in Patients With Deep Vein Thrombosis or Pulmonary Embolism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 主要终点
- Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE))
研究概览
简要总结
This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed informed Consent.
- •Patients with venous thromboembolism who are treated with anti-coagulant according to the current guidelines
排除标准
- •Patients in need of or already treated with lipid lowering drugs
- •Active liver or kidney disease or dysfunction or muscle disorders
- •Unstable medical or psychological condition that interferes with study participation
- •Pregnant woman or woman with childbearing potential who are not willing to use contraception
- •History of statin-related muscular pain, or hypersensitivity to statins
研究组 & 干预措施
1
Experimental
Oral Treatment
干预措施: Rosuvastatin (AZD4522) (Drug)
2
Placebo Comparator
Oral treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE))
时间窗: Time to first occurrence in the overall treatment period, with a median treatment period of 9,5 months
次要结局
- All cause mortality(Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months)
- Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE)(Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period)
研究者
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