Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function - Full Text View

Sponsor:	University of Oxford
Collaborator:	Merck KGaA
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00232531

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:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: MRI Scans

Drug Information available for: Niacin Niacin hydrochloride

U.S. FDA Resources

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

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

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

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Antimetabolites
Vasodilator Agents
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs
Vascular Diseases

Arteriosclerosis
Cardiovascular Agents
Pharmacologic Actions
Nicotinic Acids
Vitamins
Therapeutic Uses
Cardiovascular Diseases
Micronutrients
Niacin

ClinicalTrials.gov processed this record on November 20, 2009