Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
Overview
- Phase
- Phase 4
- Intervention
- Intensive targeting group
- Conditions
- Cardiovascular Disease
- Sponsor
- Yonsei University
- Enrollment
- 1200
- Locations
- 1
- Primary Endpoint
- Clinical efficacy of intensive lipid-lowering therapy
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Although there have been studies regarding intensive lowering of low-density lipoprotein (LDL)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. Therefore, this study sought to compare the clinical outcomes according to the LDL-cholesterol therapy targeting (intensive targeting [LDL-cholesterol <55mg/dL] vs. conventional therapy [moderate intensity statin therapy]) in elderly patients with ≥75 years and documented cardiovascular disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥75 years
- •Documented cardiovascular disease (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 or coronary artery bypass graft) D. Or peripheral artery disease.
Exclusion Criteria
- •MI or stroke within 1 year
- •LDL-cholesterol level less than 55 mg/dL without statin therapy
- •Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
- •Allergy or hypersensitivity to any statin
- •Life expectancy less than 1 years
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Arms & Interventions
Intensive targeting group
Intensive lipid loweroing therapy with LDL-cholesterol goal of \<55mg/dL
Intervention: Intensive targeting group
Conventional therapy group
Initiate and maintain moderate intensity statin therapy
Intervention: Conventional therapy group
Outcomes
Primary Outcomes
Clinical efficacy of intensive lipid-lowering therapy
Time Frame: 3 years
Composite of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, coronary revascularization, and hospitalization for angina
Secondary Outcomes
- Efficacy endpoint(3 years)
- Safety endpoint(3 years)