High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly
Condition: Atherosclerosis; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Intervention: any statin; niacin; Placebo
Intervention description: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months; long-acting niacin daily for 18 months; matching placebo pill daily for 18 months
Intervention MeSH terms: Niacin; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Pravastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: atherosclerotic plaque; MRI; inflammatory markers; statins

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.
    

Eligibility 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