High-Density Lipoprotein (HDL) Cholesterol Increased Plaque Stabilization in the Elderly (NIA-Plaque)
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| ClinicalTrials.gov Identifier: NCT00127218 |
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Recruitment Status :
Completed
First Posted : August 5, 2005
Results First Posted : November 9, 2015
Last Update Posted : November 6, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atherosclerosis Cardiovascular Disease | Drug: any statin Drug: niacin Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 145 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | HDL Increased Plaque Stabilization in the Elderly |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | December 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 1
any statin plus niacin
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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 |
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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 |
- 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.
- Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization) [ Time Frame: 18 months ]Cerebrovascular events (newly diagnosed) such as Stroke and Myocardial revascularization (specifically coronary artery bypass grafting, percutaneous coronary interventions, carotid endarterectomy) were recorded
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127218
| United States, Maryland | |
| Johns Hopkins Unversity School of Medicine | |
| Baltimore, Maryland, United States, 21218 | |
| Principal Investigator: | Joao AC Lima, MD, MBA | Johns Hopkins University |
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00127218 |
| Other Study ID Numbers: |
NA_00035188 5R01AG021570-03 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 5, 2005 Key Record Dates |
| Results First Posted: | November 9, 2015 |
| Last Update Posted: | November 6, 2017 |
| Last Verified: | October 2017 |
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atherosclerotic plaque MRI inflammatory markers statins |
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Cardiovascular Diseases Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Niacin Atorvastatin Rosuvastatin Calcium Simvastatin Pravastatin Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Vasodilator Agents Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |