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

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Yonsei University

Status and phase

Enrolling
Phase 4

Conditions

Cardiovascular Disease

Treatments

Drug: Conventional therapy group
Drug: Intensive targeting group

Study type

Interventional

Funder types

Other

Identifiers

NCT05361421
4-2022-0259

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,200 participants in 2 patient groups

Intensive targeting group
Experimental group
Description:
Intensive lipid loweroing therapy with LDL-cholesterol goal of <55mg/dL
Treatment:
Drug: Intensive targeting group
Conventional therapy group
Active Comparator group
Description:
Initiate and maintain moderate intensity statin therapy
Treatment:
Drug: Conventional therapy group

Trial contacts and locations

1

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Central trial contact

Byeong-Keuk Kim

Data sourced from clinicaltrials.gov

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