High-Density Lipoprotein (HDL) Modulation and Endothelial Function
HDL Modulation and Endothelial Function
2 other identifiers
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedNovember 10, 2008
November 1, 2008
2.9 years
September 6, 2005
November 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brachial artery flow mediated dilation
12 weeks
Secondary Outcomes (2)
Forearm pulse arterial tonometry (PAT)
12 weeks
Peak hyperemic velocity
12 weeks
Interventions
atorvastatin 80 mg for all, randomized to 1500 mg niacin/placebo and then crossed over
Eligibility Criteria
You may qualify if:
- Aged 18-80 years
- Coronary artery disease
You may not qualify if:
- 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
- Abnormalities of complete blood count (CBC), creatinine or ALT
- Change in endothelial modulating drugs in the last month or use of niacin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Calgarylead
- Heart and Stroke Foundation of Ontariocollaborator
Study Sites (1)
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Related Publications (1)
Philpott AC, Hubacek J, Sun YC, Hillard D, Anderson TJ. Niacin improves lipid profile but not endothelial function in patients with coronary artery disease on high dose statin therapy. Atherosclerosis. 2013 Feb;226(2):453-8. doi: 10.1016/j.atherosclerosis.2012.10.067. Epub 2012 Nov 5.
PMID: 23174368DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Todd J Anderson, MD
University of Calgary
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
September 1, 2005
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
November 10, 2008
Record last verified: 2008-11