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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00127218
First received: August 3, 2005
Last updated: August 27, 2010
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Cardiovascular Disease
Drug: any statin
Drug: niacin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HDL Increased Plaque Stabilization in the Elderly

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to multiple combined events ( cardiovascular and cerebrovascular events, myocardial revascularization as well as all cause and cardiovascular death) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: September 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
statin plus niacin
Drug: any statin
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
Other Names:
  • fluvastatin (Lescol)
  • pravastatin (Pravachol)
  • simvastatin (Vytorin)
  • atorvastatin (Lipitor)
  • rosuvastatin (Crestor)
Drug: niacin
long-acting niacin daily for 18 months
Placebo Comparator: 2
statin plus placebo
Drug: any statin
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
Other Names:
  • fluvastatin (Lescol)
  • pravastatin (Pravachol)
  • simvastatin (Vytorin)
  • atorvastatin (Lipitor)
  • rosuvastatin (Crestor)
Drug: Placebo
matching placebo pill daily for 18 months

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 individuals with cardiovascular disease. The specific aims of testing this hypothesis are:

  1. to determine the effects of statin plus placebo vs. statin plus niacin therapy on plaque size and composition,
  2. to determine whether alterations of inflammatory markers of atherosclerosis induced by lipid lowering therapy parallel alterations of plaque architecture and composition in older patients with cardiovascular disease,
  3. to determine the effects of these interventions on the incidence of cardiovascular and cerebrovascular events.

The results of the trial will be directly applicable to developing strategies for plaque stabilization in the elderly who suffer the most from the severe complications of advanced cardiovascular atherosclerosis.

A total of 144 participants aged 65 and older with cardiovascular or cerebrovascular disease will be recruited. Participants will be randomized to receive either statin plus niacin or statin plus a placebo for 18 months. 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. Ten visits are expected, initially every 4 weeks for dose adjustment. Then visits will be every 6 months; MRI, Inflammatory Markers tests, and other lab tests will be done at baseline and the visits at months 6, 12, and 18.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127218

Locations
United States, Maryland
Johns Hopkins Unversity School of Medicine
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Joao AC Lima, MD, MBA Johns Hopkins University
  More Information

Publications:
Responsible Party: Joao A.C. Lima, MD, MBA, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00127218     History of Changes
Other Study ID Numbers: AG0032, 5R01AG021570-03
Study First Received: August 3, 2005
Last Updated: August 27, 2010
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
atherosclerotic plaque
MRI
inflammatory markers
statins

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Niacin
Simvastatin
Atorvastatin
Fluvastatin
Pravastatin
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014