High-Density Lipoprotein (HDL) Modulation and Endothelial Function - Full Text View

Sponsor:	University of Calgary
Collaborator:	Heart and Stroke Foundation of Ontario
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00150722

Purpose

It is well known that lowering low-density lipoprotein (LDL) (bad cholesterol) is beneficial for decreasing heart attacks and death. More recently, focus has been on trying to raise HDL (good) cholesterol. The purpose of the present study is to determine if the addition of a sustained release preparation of niacin (Niaspan - a medicine to raise HDL cholesterol) to LDL lowering with a statin type medication results in improved vascular health. The study of the well being of one's vessel wall (endothelial function) will serve as a marker of treatment effect in the study.

Hypotheses: Extended-release (ER) niacin will improve endothelial function measured as brachial flow-mediated dilation (FMD - 10 end-point) and as pulse volume amplitude by pulse arterial tonometry (PAT) (20 end-point) in subjects with established atherosclerosis whose LDL cholesterol is optimally treated with statin therapy.

Condition	Intervention	Phase
Atherosclerosis	Drug: atorvastatin (or other tolerated statin + Niaspan/placebo)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	HDL Modulation and Endothelial Function

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Statins

Drug Information available for: Niacin Atorvastatin Atorvastatin calcium Niacin hydrochloride

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Brachial artery flow mediated dilation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Forearm pulse arterial tonometry (PAT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Peak hyperemic velocity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	September 2005
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

atorvastatin 80 mg for all, randomized to 1500 mg niacin/placebo and then crossed over

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aged 18-80 years
Coronary artery disease

Exclusion Criteria:

HDL > 1.10 (men), > 1.30 (women)
PCI within 30 days or CABG within 90 days
Symptomatic congestive heart failure (CHF)
Uncontrolled hypertension
Gout or active gallbladder disease, liver disease or peptic ulcer disease
Diabetes (or if Fasting blood sugar > 7.0 then hemoglobin A1c [HbA1C] > 6.1 is exclusionary)
Abnormalities of complete blood count (CBC), creatinine or ALT
Change in endothelial modulating drugs in the last month or use of niacin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150722

Locations

Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9

Sponsors and Collaborators

University of Calgary

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:

Todd J Anderson, MD

University of Calgary

More Information

No publications provided

Responsible Party:	Todd Anderson - Principle Investigator, University of Calgary
ClinicalTrials.gov Identifier:	NCT00150722 History of Changes
Other Study ID Numbers:	Ethics 18228, TPD 096237, Heart and Stroke Foundation
Study First Received:	September 6, 2005
Last Updated:	November 7, 2008
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

atherosclerosis
endothelial function
HDL

Niacin
statins
Stable Atherosclerotic Vascular Disease

Additional relevant MeSH terms:

Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012