Phase 3
N=145
High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly
Atherosclerosis · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00127218 ↗Enrolled (actual)
145
Serious AEs
1.4%
Results posted
Nov 2015
Primary outcome: Primary: Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries — 7; 5 percentage of internal carotid artery
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- any statin (Drug); niacin (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries |
7; 5 | — |
| SECONDARY Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization) |
6; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT00127218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.