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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01391377
Registration number
NCT01391377
Ethics application status
Date submitted
5/04/2011
Date registered
12/07/2011
Date last updated
27/02/2013
Titles & IDs
Public title
Effects of Niacin on Good Cholesterol in People With Peripheral Arterial Disease
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Scientific title
The Effects of Chronic High-density Lipoprotein (HDL) Elevation With Extended Release Niacin on Peripheral Arterial Disease
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Secondary ID [1]
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126-11
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Niacin/Laropiprant combination
Treatment: Drugs - Sugar pill
Active comparator: Niacin / Laropiprant -
Placebo comparator: Sugar Pill (Placebo) -
Treatment: Drugs: Niacin/Laropiprant combination
Niacin 1g / Laropiprant 20mg for 4 weeks followed by Niacin 2g / Laropiprant 20mg for 4 weeks
Treatment: Drugs: Sugar pill
Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Plaque composition
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Assessment method [1]
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After femoral arthrectomy the excised plaque will analysed for histological studies, for lipid content, immunohistochemistry, macrophage content and size and VCAM-1 staining.
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Timepoint [1]
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8 weeks after recruitment.
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Secondary outcome [1]
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Plasma Monocyte Activation
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Assessment method [1]
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Cd11b expression on peripheral blood monocytes will be measured as a marker of monocyte activation.
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Timepoint [1]
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8 weeks after recruitment
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Secondary outcome [2]
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Plasma Neutrophil Adhesion to Immobilized Fibrinogen
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Assessment method [2]
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Timepoint [2]
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8 weeks after recruitment
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Secondary outcome [3]
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Platelet Aggregation Assays
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Assessment method [3]
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Timepoint [3]
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8 weeks after recruitment
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Secondary outcome [4]
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Plasma Thrombotic Markers
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Assessment method [4]
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Timepoint [4]
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8 weeks after recruitment
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Secondary outcome [5]
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Size distribution and composition of HDL
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Assessment method [5]
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Timepoint [5]
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8 weeks after recruitment
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Secondary outcome [6]
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Ex vivo cholesterol efflux
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Assessment method [6]
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Timepoint [6]
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8 weeks after recruitment
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Secondary outcome [7]
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Plasma lipid parameters and inflammatory markers
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Assessment method [7]
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Lipid levels including total cholesterol, HDL, LDL and TGs, will be measured as well as ApoA1 protien and Plasma soluble ICAM-1 and soluble VCAM-1. TNF-A levels will also be measured and CRP.
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Timepoint [7]
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8 weeks after recruitment
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Eligibility
Key inclusion criteria
* age >40 years
* ankle-brachial index (ABI) of <0.9 at rest in at least one leg,
* symptom limiting intermittent claudication (unilateral or bilateral) and stable for the previous 6 months,
* superficial femoral artery disease amenable to percutaneous revascularisation,
* serum HDL <1.0 mmol/l
* a stable medication regime for at least 6 months
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* acute myocardial infarction or presentation with angina within 1 month of enrolment,
* serum creatinine >0.2mmol/l,
* significant co-morbidity with expected survival <6 months,
* current niacin or fibrate therapy
* unable to give informed consent
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2014
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Actual
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Sample size
Target
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Accrual to date
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Final
7
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker IDI Heart and diabetes research institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Atherosclerosis is a disorder in the body that is characterized by cholesterol plaque formation in various arteries, causing narrowing of the artery and a limitation in blood flow. Depending on which artery the plaque is in, different clinical conditions occur. In adults common areas include in the heart arteries, in the neck arteries and in the aorta and lower leg arteries. When it affects the lower limbs it is known as peripheral arterial disease - PAD. The main symptom of PAD is called "claudication" and is described as pain or discomfort in the legs when walking. The aim of PAD treatment is to improve walking distance and quality of life in those with intermittent claudication, and to decrease long term complications including illness and death. An important controlling factor of these cholesterol plaques is a type of cholesterol called HDL (High density lipoprotein). This study aims to look at the effect that raising HDL for a prolonged period has on blood markers of inflammation and on the cholesterol plaque composition in patients with PAD. This investigation will also have relevance to the effects of HDL elevation on plaque composition and inflammation in other areas of the body including the heart, neck and brain arteries. Twenty (20) PAD patients with will be recruited into the study. The investigators anticipate recruitment of all 20 patients within 12 months. The 20 PAD patients all must have significant leg pains when walking, and after review by a doctor, be determined to have narrowings in the leg artery that they will plan to operate on. Patients will be randomized to either niacin (Tredaptive, 1g/day) or matching placebo for 8 weeks (prior to operation) After the 8 week period they will then go on to receive the normal interventional treatment as planned. Blood samples will be taken at enrollment and at the 8 week mark prior to surgery. The plaque that is removed at the time of operation will also be sent to the lab for analysis. The investigators hope to show with this study that by raising the levels of HDL with extended release niacin, there are positive effects on the amount of cholesterol in the plaque, and on the markers in the blood of inflammation and thrombosis. The hypothesis is that elevation of HDL with Niacin will have anti-atherosclerotic actions including: Lower plaque lipid content, Reduced plaque macrophage infiltration, Reduced monocyte activation, Reduced neutrophil adhesion, Inhibition of inflammation and Inhibition of thrombotic markers.
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Trial website
https://clinicaltrials.gov/study/NCT01391377
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bronwyn Kingwell, Bsc, PhD
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Address
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Baker IDI
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01391377
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