Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function
Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
1 other identifier
interventional
70
1 country
1
Brief Summary
AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established atherosclerosis. The investigators will therefore study patients with atherosclerosis in the aorta and carotid artery. Plaque quantification will be with magnetic resonance imaging (MRI). AIM 2 will assess the ability of Niaspan to improve endothelial function in patients with coronary artery disease and type II diabetes mellitus, who typically have low high-density lipoprotein cholesterol (HDL-C), and high risk of cardiovascular events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 3, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJanuary 29, 2007
September 1, 2006
October 3, 2005
January 26, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
Interventions
Eligibility Criteria
You may qualify if:
- Aim 1: Carotid or peripheral arterial disease and HDL \<1mmol/L
- Aim 2: Coronary artery disease, type II diabetes and HDL \<1mmol/L
You may not qualify if:
- Inability to provide informed consent,
- Known intolerance of a study drug,
- Use of niacin or a fibrate at time of screening,
- AST or ALT elevated above normal range at time of screening
- Use of oral nitrates or nicorandil
- Uncontrolled or newly diagnosed diabetes mellitus
- Symptomatic heart failure or heart failure requiring treatment with diuretics
- Fasting triglycerides \> 500mg/dL \[5.65mmol/L\]
- Patients with acute coronary syndromes, active peptic ulcer disease,
- Active gout,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Merck KGaA, Darmstadt, Germanycollaborator
Study Sites (1)
Oxford University
Oxford, United Kingdom
Related Publications (1)
Lee JM, Robson MD, Yu LM, Shirodaria CC, Cunnington C, Kylintireas I, Digby JE, Bannister T, Handa A, Wiesmann F, Durrington PN, Channon KM, Neubauer S, Choudhury RP. Effects of high-dose modified-release nicotinic acid on atherosclerosis and vascular function: a randomized, placebo-controlled, magnetic resonance imaging study. J Am Coll Cardiol. 2009 Nov 3;54(19):1787-94. doi: 10.1016/j.jacc.2009.06.036.
PMID: 19874992DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin P Choudhury, DM, MRCP
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 3, 2005
First Posted
October 4, 2005
Study Start
September 1, 2004
Study Completion
February 1, 2009
Last Updated
January 29, 2007
Record last verified: 2006-09