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

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0008233

Lead Sponsor: Kangbuk Samsung Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1584

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of cardiac death, myocardial infarction, stroke, stent thrombosis or coronary revascularization procedures Severe limb ischemia leading to angioplasty (angioplasty, bypass surgery, amputation, thrombolysis), major amputation of the upper ankle due to vascular causes

Secondary Outcome Measures