Effect of Intensive LDL-cholesterol Targeting for Elderly Patients with Cardiovascular Disease : I-OLD Trial
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 1200
1. Age =75 years
2. Documented CVD (at least 1 of the following)
A. Previous acute coronary syndrome (MI or unstable angina),
B. Or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia
C. Or coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG])
D. Or peripheral artery disease.
1. MI or stroke within 1 year
2. LDL-cholesterol level less than 55 mg/dL without statin therapy
3. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
4. Allergy or hypersensitivity to any statin
5. Life expectancy less than 1 years
6. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
7. Inability to understand or read the informed content
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, and hospitalization for angina
- Secondary Outcome Measures
Name Time Method 1. New-onset DM, worsening of glycemic control, or homeostatic model assessment (HOMA)-index 2. Occurrence of statin-associated muscle symptoms (SAMS) requiring change or regimen or dosage 3. Elevation of muscle enzymes (CPK > 4 x UNL) 4. Elevation of hepatic enzymes (AST, ALT, or both = 3 x UNL) 5. Elevation of serum creatinine level (>50% from baseline) 6. Change of proteinuria 7. Diagnosis of cancer 8. Operation due to cataract 9. Major bleeding (BARC 2, 3, or 5)