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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00712049
First received: July 3, 2008
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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
Dyslipidemia
Atherosclerosis
Drug: simvastatin
Drug: Nicotinic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2008
Arms Assigned Interventions
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
Simvastatin
Drug: simvastatin
simvastatin 40 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712049

Locations
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.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Renate Koppensteiner, Prof. Dr. Division of Angiology, Department of Internal Medicine II, Medical University Vienna
  More Information

No publications provided

Responsible Party: Prof. Dr. Renate Koppensteiner, Medical University Vienna
ClinicalTrials.gov Identifier: NCT00712049     History of Changes
Other Study ID Numbers: Version 1.0-2007
Study First Received: July 3, 2008
Last Updated: July 20, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
intima-media-thickness
dyslipidemia
progression of atherosclerosis
peripheral artery disease
major cardiovascular events

Additional relevant MeSH terms:
Nicotinic Acids
Niacin
Niacinamide
Atherosclerosis
Arteriosclerosis
Dyslipidemias
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Peripheral Vascular Diseases
Simvastatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014