Effects of Nicotinic Acid Plus Simvastatin Versus Simvastatin Alone on Carotid and Femoral Intima-Media Thickness in Patients With Peripheral Artery Disease (NASCIT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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Dyslipidaemia is characterized by low plasma levels of high-density lipoprotein cholesterol (HDL-c), elevated triglycerides and an increase in low density lipoprotein (LDL-c) particles, and has been unequivocally established as a most important cardiovascular risk factor. While statins are effective in reducing plasma levels of LDL-c, these drugs have only modest effects on raising HDL-c (typically by less than 10%), even with aggressive statin therapy. However, increasing evidence suggests that low HDL-c might be at least as relevant as high LDL-c in promoting the development and progression of atherosclerosis. The beneficial effect of raising HDL-c on clinical outcome has already been demonstrated by several studies.

Nicotinic acid is the most potent agent available for raising plasma levels of HDL-c by up to 29% at clinically recommended doses, and substantially lowers triglycerides and LDL-c. Furthermore, nicotinic acid is also the most potent lipid lowering agent available that reduces Lp(a), an independent marker of cardiovascular risk. In a recent study patients with coronary artery disease had a 21% increase in HDL-c and a 13% decrease in triglycerides, and these beneficial effects on lipid status may have contributed to a stabilization or regression of carotid intima-media-thickness (IMT).The impact in patients with advanced atherosclerosis like peripheral artery disease (PAD) in unknown.

The investigators hypothesized that nicotinic acid in addition to statin therapy may inhibit progression of peripheral arterial atherosclerosis. Therefore, the aim of the present randomized controlled trial is to investigate the effects of nicotinic acid (daily dose starting with 500 mg, up to 2000mg) in addition to simvastatin (40 mg daily) versus simvastatin (40mg daily) monotherapy in patients with low serum HDL-C levels and PAD with respect to changes of carotid and femoral IMT, changes of patients´ lipid status and occurrence of major adverse cardiovascular events (MACE).

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Detailed Description

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Conditions

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Dyslipidemia Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Nicotinic acid + Simvastatin

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

simvastatin 40 mg

Nicotinic Acid

Intervention Type DRUG

daily dose starting with 500 mg, up to 2000mg

2

Simvastatin

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

simvastatin 40 mg

Interventions

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simvastatin

simvastatin 40 mg

Intervention Type DRUG

Nicotinic Acid

daily dose starting with 500 mg, up to 2000mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* PAD defined as an ABI ≤0.9 or \>1.3 in patients with low serum HDL cholesterol levels (\<45mg/dL in men, \<55 mg/dL in women)

Exclusion Criteria

* Elevated liver enzymes (above 2 times the normal level)
* Skeletal muscle myopathy or elevated serum CK levels
* Allergy or hypersensibility to either statins or nicotinic acid
* Women of childbearing potential

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No