Back to resultsOxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function
Primary Purpose
Atherosclerosis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Niaspan
Sponsored by
About this trial
This is an interventional prevention trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria: Aim 1: Carotid or peripheral arterial disease and HDL <1mmol/L Aim 2: Coronary artery disease, type II diabetes and HDL <1mmol/L Exclusion Criteria: The following will constitute exclusion criteria: 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, Standard exclusions for MRI will apply, i.e. pacemakers, implantable defibrillators, metal implants or embedded metallic fragments of any kind.
Sites / Locations
- Oxford University
Outcomes
Primary Outcome Measures
Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
Secondary Outcome Measures
Full Information
NCT ID
NCT00232531
First Posted
October 3, 2005
Last Updated
January 26, 2007
Sponsor
University of Oxford
Collaborators
Merck KGaA, Darmstadt, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00232531
Brief Title
Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function
Official Title
Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oxford
Collaborators
Merck KGaA, Darmstadt, Germany
4. Oversight
5. Study Description
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.
Detailed Description
Patients will be randomised to receive either Niaspan 2000mg each night or placebo. Niaspan will be commenced at 375mg daily and increased to 500mg then to 750, and 1000mg daily at weekly intervals. After 4 weeks the dose will be increased to 1500mg daily and, after a further one month, the study dose of 2000mg daily2 will be instigated. Immediately before randomization (to exclude patients unable to tolerate MRI because of claustrophobia), and 6 and 12 months after commencing treatment participants will undergo MR examination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Niaspan
Primary Outcome Measure Information:
Title
Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aim 1: Carotid or peripheral arterial disease and HDL <1mmol/L
Aim 2: Coronary artery disease, type II diabetes and HDL <1mmol/L
Exclusion Criteria:
The following will constitute exclusion criteria:
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,
Standard exclusions for MRI will apply, i.e. pacemakers, implantable defibrillators, metal implants or embedded metallic fragments of any kind.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin P Choudhury, DM, MRCP
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford University
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
19874992
Citation
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.
Results Reference
derived
Learn more about this trial
Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function
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