KCT0008233招募中未知
Guideline-directed high intensity statin only therapy versus statin with ezetimibe combination therapy in patients with polyvascular disease including coronary artery disease and peripheral artery disease: a multicenter prospective randomized open-label trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 1,584
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older with both of the following diseases
- •1) Coronary artery disease
- •Patients with clinically diagnosed coronary artery disease. Coronary artery disease includes stable angina pectoris, unstable angina pectoris, acute non-ST-segment elevation myocardial infarction, and acute ST-segment elevation myocardial infarction.
- •2) Peripheral vascular disease
- •Patients who have previously undergone aortofemoral bypass surgery, limb bypass surgery, or percutaneous angioplasty of the ilium or lower artery.
- •Patients who have undergone limb or foot amputation for arterial vascular disease.
- •Patients with intermittent claudication who satisfy one or all of the following conditions
- •a) Ankle-brachial index (ABI) less than 0.9
- •b) Confirmation of 50% or more peripheral vascular stenosis by angiography or Doppler ultrasound
- •Asymptomatic patients who have undergone previous carotid artery recanalization or have carotid artery stenosis of 50% or more confirmed by angiography or Doppler ultrasound
- •- Patients who consented to the study
排除标准
- •Patients who are breastfeeding or planning to become pregnant during the study period
- •- Those with a history of serious side effects or hypersensitivity to statins
- •- Patients who are currently taking drugs with strong interactions with statins (cytochrome p-450 3A4 or 2C9 inhibitors)
- •- Those with risk factors for myopathy or rhabdomyolysis, such as hereditary muscle disorder, hypothyroidism, alcoholism, severe liver dysfunction (more than 3 times the normal value)
- •- Patients with life expectancy less than 3 years
- •- If it is judged that follow-up for more than 1 year is not possible
- •- If you cannot understand or read the consent form
研究者
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