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High-Density Lipoprotein (HDL) Modulation and Endothelial Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150722
First Posted: September 8, 2005
Last Update Posted: November 10, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
University of Calgary
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HDL Modulation and Endothelial Function

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Brachial artery flow mediated dilation [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Forearm pulse arterial tonometry (PAT) [ Time Frame: 12 weeks ]
  • Peak hyperemic velocity [ Time Frame: 12 weeks ]

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:
    Drug: atorvastatin (or other tolerated statin + Niaspan/placebo)
    atorvastatin 80 mg for all, randomized to 1500 mg niacin/placebo and then crossed over
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: November 10, 2008
Last Verified: November 2008

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 Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors