AtherosclerosisNCT00232531
Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function
A study testing Niaspan in people with Atherosclerosis, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Niaspan
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2004to Feb 2009
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aim 1: Carotid or peripheral arterial disease and HDL <1mmol/L
- Aim 2: Coronary artery disease, type II diabetes and HDL <1mmol/L
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiovascular Magnetic Resonance Evaluation of the Effects of Niaspan on Regression of Atherosclerosis and Restoration of Endothelial Function
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- Niaspan
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiaspanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of artheriosclerotic plaque measured using functional magnetic resonance imaging.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startSep 2004
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Investigators
- Robin P Choudhury, DM, MRCP, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00232531
- Sponsor's protocol ID
- 04.OXA.020
- Status last verified
- Sep 2006
- First submitted
- 3 Oct 2005
- Last updated
- 29 Jan 2007
- Results posted
- No
Publications
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.
PubMed 19874992