Peripheral Arterial Disease Clinical Trial
Official title:
The Effects of Chronic High-density Lipoprotein (HDL) Elevation With Extended Release Niacin on Peripheral Arterial Disease
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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