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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00712049 |
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).
Condition | Intervention | Phase |
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Dyslipidemia Atherosclerosis |
Drug: simvastatin Drug: Nicotinic Acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Nicotinic Acid Plus Simvastatin Versus Simvastatin Alone on Carotid and Femoral Intima-Media Thickness in Patients With Peripheral Artery Disease (NASCIT)-A Randomized Controlled Trial |
Estimated Enrollment: | 200 |
Study Start Date: | June 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
Nicotinic acid + Simvastatin
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Drug: simvastatin
simvastatin 40 mg
Drug: Nicotinic Acid
daily dose starting with 500 mg, up to 2000mg
|
2: Active Comparator
Simvastatin
|
Drug: simvastatin
simvastatin 40 mg
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Medical University Vienna | Recruiting |
Vienna, Austria, 1090 | |
Contact: Renate Koppensteiner, Prof. Dr. 00431404004671 renate.koppensteiner@meduniwien.ac.at | |
Sub-Investigator: Martin Schillinger, Prof. Dr. | |
Sub-Investigator: Jasmin Amighi, Dr. | |
Sub-Investigator: Schila Sabeti, Dr. |
Principal Investigator: | Renate Koppensteiner, Prof. Dr. | Division of Angiology, Department of Internal Medicine II, Medical University Vienna |
Responsible Party: | Medical University Vienna ( Prof. Dr. Renate Koppensteiner ) |
Study ID Numbers: | Version 1.0-2007 |
Study First Received: | July 3, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00712049 History of Changes |
Health Authority: | Austria: Agency for Health and Food Safety |
intima-media-thickness dyslipidemia progression of atherosclerosis peripheral artery disease major cardiovascular events |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Vasodilator Agents Vitamin B Complex Metabolic Diseases Niacinamide Simvastatin Antilipemic Agents Disease Progression Vascular Diseases Trace Elements |
Anticholesteremic Agents Cardiovascular Agents Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Nicotinic Acids Vitamins Micronutrients Metabolic Disorder Niacin Dyslipidemias Lipid Metabolism Disorders |
Atherosclerosis Antimetabolites Vasodilator Agents Niacinamide Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Arteriosclerosis Nicotinic Acids Vitamins Therapeutic Uses Cardiovascular Diseases Micronutrients Dyslipidemias Arterial Occlusive Diseases |
Vitamin B Complex Metabolic Diseases Simvastatin Growth Substances Antilipemic Agents Vascular Diseases Enzyme Inhibitors Anticholesteremic Agents Cardiovascular Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Niacin Lipid Metabolism Disorders |