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

NCT00127218 | Completed Phase 3 Results DMC

• 2 other identifiers: NA_000351885R01AG021570-03
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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 current guidelines, in older individuals with cardiovascular disease.

Conditions

Atherosclerosis; Cardiovascular Disease

Keywords

atherosclerotic plaque; MRI; inflammatory markers; statins

Outcome Measures

Primary Outcomes (1)

• Changes in Plaque Architecture and Composition Directly Measured by Magnetic Resonance Imaging (MRI) in the Aorta and Carotid Arteries

  The primary endpoint is Changes in plaque architecture and composition directly measured by magnetic resonance imaging (MRI) in the aorta and carotid arteries.

  18 months

Secondary Outcomes (1)

• Multiple Combined Events ( Cardiovascular and Cerebrovascular Events as Well as Myocardial Revascularization)

  18 months

Study Arms (2)

1

EXPERIMENTAL

any statin plus niacin

Drug: any statin; Drug: niacin

2

PLACEBO COMPARATOR

any statin plus placebo

Drug: any statin; Drug: Placebo

Interventions

any statin DRUG

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

Also known as: fluvastatin (Lescol), pravastatin (Pravachol), simvastatin (Vytorin), atorvastatin (Lipitor), rosuvastatin (Crestor)

1; 2

niacin DRUG

long-acting niacin daily for 18 months

1

Placebo DRUG

matching placebo pill daily for 18 months

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins Unversity School of Medicine

Baltimore, Maryland, 21218, United States

Location

Related Publications (3)

• Guyton JR, Goldberg AC, Kreisberg RA, Sprecher DL, Superko HR, O'Connor CM. Effectiveness of once-nightly dosing of extended-release niacin alone and in combination for hypercholesterolemia. Am J Cardiol. 1998 Sep 15;82(6):737-43. doi: 10.1016/s0002-9149(98)00448-2.

  PMID: 9761083 BACKGROUND

• Ballantyne CM, Herd JA, Ferlic LL, Dunn JK, Farmer JA, Jones PH, Schein JR, Gotto AM Jr. Influence of low HDL on progression of coronary artery disease and response to fluvastatin therapy. Circulation. 1999 Feb 16;99(6):736-43. doi: 10.1161/01.cir.99.6.736.

  PMID: 9989957 BACKGROUND

• Brown BG, Zhao XQ, Chait A, Fisher LD, Cheung MC, Morse JS, Dowdy AA, Marino EK, Bolson EL, Alaupovic P, Frohlich J, Albers JJ. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med. 2001 Nov 29;345(22):1583-92. doi: 10.1056/NEJMoa011090.

  PMID: 11757504 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Plaque, Atherosclerotic

Interventions

Fluvastatin; Pravastatin; Simvastatin; Ezetimibe, Simvastatin Drug Combination; Atorvastatin; Rosuvastatin Calcium; Niacin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Lovastatin; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations; Pyrroles; Azoles; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Results Point of Contact

• Title: Dr. Joao AC Lima
• Organization: The Johns Hopkins Hospital, Department of Medicine, Division of Cardiology

jlima@jhmi.edu

410-614-1284

Study Officials

• Joao AC Lima, MD, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2005
• First Posted: August 5, 2005
• Study Start: September 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 6, 2017
• Results First Posted: November 9, 2015

Record last verified: 2017-10

Locations

US (1)