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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00712049
Recruitment Status : Unknown
Verified July 2011 by Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : July 9, 2008
Last Update Posted : July 22, 2011
Information provided by:
Medical University of Vienna

Brief Summary:

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 or disease Intervention/treatment Phase
Dyslipidemia Atherosclerosis Drug: simvastatin Drug: Nicotinic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Nicotinic acid + Simvastatin
Drug: simvastatin
simvastatin 40 mg

Drug: Nicotinic Acid
daily dose starting with 500 mg, up to 2000mg

Active Comparator: 2
Drug: simvastatin
simvastatin 40 mg

Primary Outcome Measures :
  1. change of carotid and femoral IMT from baseline to 6 and 12 months follow up and occurrence of major adverse cardiovascular events (MACE) [ Time Frame: 6 and 12 months ]

Secondary Outcome Measures :
  1. changes of grey scale median (GSM) score from baseline to follow-up, and changes of serum levels of total cholesterol, low-density lipoprotein cholesterol (LDL-c), high-density lipoprotein cholesterol (HDL-c), triglycerides and lipoprotein (a). [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00712049

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Medical University Vienna Recruiting
Vienna, Austria, 1090
Contact: Renate Koppensteiner, Prof. Dr.    00431404004671   
Sub-Investigator: Martin Schillinger, Prof. Dr.         
Sub-Investigator: Jasmin Amighi, Dr.         
Sub-Investigator: Schila Sabeti, Dr.         
Sponsors and Collaborators
Medical University of Vienna
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Principal Investigator: Renate Koppensteiner, Prof. Dr. Division of Angiology, Department of Internal Medicine II, Medical University Vienna
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Responsible Party: Prof. Dr. Renate Koppensteiner, Medical University Vienna Identifier: NCT00712049    
Other Study ID Numbers: Version 1.0-2007
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011
Keywords provided by Medical University of Vienna:
progression of atherosclerosis
peripheral artery disease
major cardiovascular events
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Peripheral Vascular Diseases
Nicotinic Acids
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Physiological Effects of Drugs
Vasodilator Agents