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Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00232531
Recruitment Status : Unknown
Verified September 2006 by University of Oxford.
Recruitment status was:  Active, not recruiting
First Posted : October 4, 2005
Last Update Posted : January 29, 2007
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by:
University of Oxford

Study Description
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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.


Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Niaspan Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
Study Start Date : September 2004
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232531


Locations
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United Kingdom
Oxford University
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Merck KGaA, Darmstadt, Germany
Investigators
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Principal Investigator: Robin P Choudhury, DM, MRCP University of Oxford
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00232531    
Other Study ID Numbers: 04.OXA.020
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: January 29, 2007
Last Verified: September 2006
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Niacin
Nicotinic Acids
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs