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

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

MedlinePlus related topics:

Cholesterol

ChemIDplus related topics:

Atorvastatin Atorvastatin calcium Niacin Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Official Title:	HDL Modulation and Endothelial Function

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 ]

Estimated Enrollment:	76
Study Start Date:	September 2005
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	June 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

Show Detailed Description

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

Contacts


Contact: Todd J Anderson, MD	403-944-1110 ext 1096	todd.anderson@calgaryhealthregion.ca

Locations


Canada, Alberta
	Foothills Medical Centre	Recruiting
	Calgary, Alberta, Canada, T2N 2T9
	Contact: Todd J Anderson, MD 403-944-1033 todd.anderson@calgaryhealthregion.ca
	Contact: Lana Shewchuk, BN 403-944-8509 shewchuk@ucalgary.ca
	Principal Investigator: Todd Anderson, MD

Sponsors and Collaborators

University of Calgary

Heart and Stroke Foundation of Ontario

Investigators


Principal Investigator:	Todd J Anderson, MD	University of Calgary

More Information

Responsible Party:	University of Calgary ( Todd Anderson - Principle Investigator )
Study ID Numbers:	Ethics 18228, TPD 096237, Heart and Stroke Foundation
First Received:	September 6, 2005
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00150722
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:

atherosclerosis

endothelial function

HDL

Niacin

statins

Stable Atherosclerotic Vascular Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases

Atherosclerosis

Nicotinic Acids

Vascular Diseases

Arteriosclerosis

Niacin

Atorvastatin

Additional relevant MeSH terms:

Antimetabolites

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Enzyme Inhibitors

Cardiovascular Diseases

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008

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