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Sponsors and Collaborators: |
University of Calgary Heart and Stroke Foundation of Ontario |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00150722 |
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 |
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Atherosclerosis |
Drug: atorvastatin (or other tolerated statin + Niaspan/placebo) |
Phase III |
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 |
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) |
Purpose: To determine the incremental value of extended-release (ER) niacin in combination with high dose statin therapy on brachial endothelial function in subjects with coronary atherosclerosis.
Hypotheses:
Subjects will have established coronary atherosclerosis and an HDL < 1.1 mmol/L, and be at least one month post percutaneous coronary intervention (PCI) or 3 months post coronary artery bypass graft (CABG). Exclusion criteria include active gout, gallbladder or peptic ulcer disease, change of endothelial modulating drugs within one month of study initiation or use of niacin. The primary end-point of the study is brachial artery flow-mediated vasodilation. The primary efficacy analysis will be a comparison of the change in FMD during active ER niacin treatment compared with baseline. The sample size is based on an expected 2% difference in FMD (SD 5%), p <0.05 and power of 80%.
Significance: Despite the reduction of mortality with current LDL lowering approaches, morbidity and mortality remain unacceptably high. HDL has recently gained favor as a therapeutic target to lower cardiovascular event rates. The current study will evaluate the effect of HDL raising on endothelial health, a surrogate marker of atherosclerosis activity.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Foothills Medical Centre | |
Calgary, Alberta, Canada, T2N 2T9 |
Principal Investigator: | Todd J Anderson, MD | University of Calgary |
Responsible Party: | University of Calgary ( Todd Anderson - Principle Investigator ) |
Study ID Numbers: | Ethics 18228, TPD 096237, Heart and Stroke Foundation |
Study First Received: | September 6, 2005 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00150722 History of Changes |
Health Authority: | Canada: Health Canada |
atherosclerosis endothelial function HDL |
Niacin statins Stable Atherosclerotic Vascular Disease |
Atherosclerosis Arterial Occlusive Diseases Antimetabolites Niacinamide Antilipemic Agents Vascular Diseases Arteriosclerosis Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Nicotinamide Nicotinic Acids Vitamin B3 Nicotinic Acid Niacin Atorvastatin |
Atherosclerosis Arterial Occlusive Diseases Antimetabolites Molecular Mechanisms of Pharmacological Action Antilipemic Agents Vascular Diseases Enzyme Inhibitors |
Arteriosclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Cardiovascular Diseases Atorvastatin |