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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00232531
Enrollment
70
Registered
2005-10-04
Start date
2004-09-30
Completion date
2009-02-28
Last updated
2007-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

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.

Interventions

Sponsors

Merck KGaA, Darmstadt, Germany
CollaboratorINDUSTRY
University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026