High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the added benefits of increased high-density lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines, in older individuals with cardiovascular disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Aging (NIA)
• Treatments: Atorvastatin; Atorvastatin Calcium; Fluvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Niacin; Niacinamide; Nicotinic Acids; Pravastatin; Rosuvastatin Calcium; Simvastatin

Criteria

Inclusion Criteria:

• Aged 65 or older

• Documented clinical cardiovascular or cerebrovascular disease due to atherosclerosis

• Candidate for lipid lowering therapy; no contraindication to fluvastatin, niacin or aspirin therapy

• Low-density lipoprotein (LDL) cholesterol below 150 mg/dl if untreated or below 125 mg/dl on statin monotherapy

• Willing to discontinue present therapy if private physician agrees with enrollment

• Eligible to undergo trans-esophageal magnetic resonance imaging (MRI); no contraindications to Gadolinium-DTPA, the contrast agent used

• Willing to sign Informed Consent

Exclusion Criteria:

• Ineligibility for MRI procedure due to pacemaker, metal implants, or other ferromagnetic devices

• Claustrophobia

• Previously documented esophageal disease which would preclude trans-esophageal MRI

• LDL-C greater than 150 mg/dl off lipid lowering therapy or daily statin therapy requiring doses greater than 20 mg of atorvastatin, 20 mg of simvastatin, 80 mg of lovastatin, 80 mg of pravastatin, 80 mg of extended release fluvastatin, or 20 mg of rosuvastatin

• Contraindication or allergy to statins or aspirin

• Current use of or known intolerance or allergy to Niaspan (a long-acting niacin)

• Allergy or intolerance to Gadolinium-DTPA (MRI contrast agent)

• Liver or kidney failure defined clinically and by laboratory data

• Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial