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

NCT00712049 | Unknown Phase 4

• 1 other identifier: Version 1.0-2007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Dyslipidemia; Atherosclerosis

Keywords

intima-media-thickness; dyslipidemia; progression of atherosclerosis; peripheral artery disease; major cardiovascular events

Outcome Measures

Primary Outcomes (1)

• change of carotid and femoral IMT from baseline to 6 and 12 months follow up and occurrence of major adverse cardiovascular events (MACE)

  6 and 12 months

Secondary Outcomes (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).

  6 and 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Nicotinic acid + Simvastatin

Drug: simvastatin; Drug: Nicotinic Acid

2

ACTIVE COMPARATOR

Simvastatin

Drug: simvastatin

Interventions

simvastatin DRUG

simvastatin 40 mg

1; 2

Nicotinic Acid DRUG

daily dose starting with 500 mg, up to 2000mg

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Dyslipidemias; Atherosclerosis; Peripheral Arterial Disease

Interventions

Simvastatin; Niacin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Renate Koppensteiner, Prof. Dr.

  Division of Angiology, Department of Internal Medicine II, Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2008
• First Posted: July 9, 2008
• Study Start: June 1, 2008
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

AU (1)