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EFFECTS OF NICOTINIC ACID PLUS SIMVASTATIN VS. SIMVASTATIN ALONE ON CAROTID AND FEMORAL INTIMA-MEDIA THICKNESS IN PATIENTS WITH PERIPHERAL ARTERY DISEASE (NASCIT) – A RANDOMIZED CONTROLLED TRIAL - NASCIT

EFFECTS OF NICOTINIC ACID PLUS SIMVASTATIN VS. SIMVASTATIN ALONE ON CAROTID AND FEMORAL INTIMA-MEDIA THICKNESS IN PATIENTS WITH PERIPHERAL ARTERY DISEASE (NASCIT) – A RANDOMIZED CONTROLLED TRIAL - NASCIT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000197-24-AT
Enrollment
Unknown
Registered
2007-03-13
Start date
2008-05-16
Completion date
Unknown
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

200 consecutive patients with PAD and low serum HDL cholesterol levels (<45mg/dL in men, <55 mg/dL in women) will be enrolled in this single-center prospective randomized controlled open-label trial.

Interventions

Trade Name: Simvastatin Merck 40mg 1-24892 Product Name: Simvastatin Merck 40mg Pharmaceutical Form: Tablet INN or Proposed INN: Simvastatin Merck Concentration number: 40mg- Trade Name: Niaspan 500m

Sponsors

MUW, Univ.Klinik f. Innere Medizin II, Abteilung f. Angiologie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 200 consecutive patients with PAD and low serum HDL cholesterol levels (1.3 in patients with low serum HDL cholesterol levels (=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria include elevated liver enzymes (above 2 times the normal level), skeletal muscle myopathy or elevated serum CK levels, and allergy or hypersensibility to either statins or nicotinic acid.

Design outcomes

Primary

MeasureTime frame
Main Objective: We 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) vs. simvastatin (40mg daily) monotherapy in patients with low serum HDL-C levels and PAD with respect to changes of carotid and femoral IMT.;Secondary Objective: We also investigated changes of patients´ lipid status and occurrence of major adverse cardiovascular events (MACE).;Primary end point(s): STUDY ENDPOINTS. The primary morphological study endpoint is the change of carotid and femoral IMT from baseline to 6 and 12 months follow up. Primary clinical endpoint is the occurrence of major adverse cardiovascular events (MACE) including myocardial infarction, percutaneous coronary interventions, coronary artery bypass surgery, stroke, amputations, occurrence of critical limb ischemia and death.—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026