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High-Density Lipoprotein (HDL) Modulation and Endothelial Function

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00150722
First received: September 6, 2005
Last updated: November 7, 2008
Last verified: November 2008
History of Changes
  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
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:

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:
    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

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 May 23, 2013