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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Oxford.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Merck KGaA
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00232531
First received: October 3, 2005
Last updated: January 26, 2007
Last verified: September 2006
  Purpose

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 Intervention
Atherosclerosis
Drug: Niaspan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.

Estimated Enrollment: 70
Study Start Date: September 2004
Estimated Study Completion Date: February 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232531

Locations
United Kingdom
Oxford University
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Merck KGaA
Investigators
Principal Investigator: Robin P Choudhury, DM, MRCP Oxford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232531     History of Changes
Other Study ID Numbers: 04.OXA.020
Study First Received: October 3, 2005
Last Updated: January 26, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Niacin
Nicotinic Acids
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014