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NCT05361421 | Recruiting | Cardiovascular Disease


Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
Sponsor:

Yonsei University

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.

Condition or disease

Cardiovascular Disease

Intervention/treatment

Intensive targeting group

Conventional therapy group

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 1200 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial
Actual Study Start Date : July 19, 2022
Estimated Primary Completion Date : October 15, 2025
Estimated Study Completion Date : October 15, 2027
Arm Intervention/treatment

Experimental: Intensive targeting group

Intensive lipid loweroing therapy with LDL-cholesterol goal of <55mg/dL

Drug: Intensive targeting group

Active Comparator: Conventional therapy group

Initiate and maintain moderate intensity statin therapy

Drug: Conventional therapy group

Ages Eligible for Study: 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial

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Effect of Intensive LDL-cholesterol Targeting for Elderly Patients With Cardiovascular Disease: I-OLD Trial

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Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Korea, Republic of,

Yonsei University Health System, Severance Hospital

Seoul, Korea, Republic of,

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