Status:
COMPLETED
High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Atherosclerosis
Cardiovascular Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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 cu...
Detailed Description
The hypothesis being tested is that the current standard lipid lowering therapy, combined with a 20 percent or greater increase in serum HDL induced by long-acting niacin, reduces plaque size in older...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00127218
Start Date
September 1 2003
End Date
December 1 2008
Last Update
November 6 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Johns Hopkins Unversity School of Medicine
Baltimore, Maryland, United States, 21218