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High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly (NIA-Plaque)
This study has been completed.
Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Joao A.C Lima, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00127218
First received: August 3, 2005
Last updated: October 12, 2015
Last verified: October 2015
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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 Joao A.C Lima, 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 ]The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.
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 ]
| Enrollment: | 145 |
| 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
any 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:
Drug: niacin
long-acting niacin daily for 18 months
|
|
Placebo Comparator: 2
any 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:
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:
- to determine the effects of statin plus placebo vs. statin plus niacin therapy on plaque size and composition,
- 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,
- 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127218
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
National Institute on Aging (NIA)
Investigators
| Principal Investigator: | Joao AC Lima, MD, MBA | Johns Hopkins University |
More Information
Publications:
| Responsible Party: | Joao A.C Lima, Professor of Medicine and Radiology, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00127218 History of Changes |
| Other Study ID Numbers: |
AG0032 5R01AG021570-03 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | August 3, 2005 |
| Results First Received: | September 1, 2015 |
| Last Updated: | October 12, 2015 |
Keywords provided by Joao A.C Lima, Johns Hopkins University:
|
atherosclerotic plaque MRI inflammatory markers statins |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Simvastatin Rosuvastatin Calcium Atorvastatin Calcium Fluvastatin Pravastatin Niacin Hydroxymethylglutaryl-CoA Reductase Inhibitors Niacinamide |
Nicotinic Acids Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 27, 2017