Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease

Overview

The purpose of this study is to determine the long-term effects of statins, atorvastatin, upon Nitric Oxide, as an endothelial function assessment, and C-Reactive Protein, an inflammatory marker, levels in patients with Peripheral Arterial Disease. These long-term biological pleiotropic effects of statins will offer information on the role of endothelial function and systemic inflammation in the etiopathogenesis of PAD.

Full Title of Study: “Phase IV Study of Statins for Assess the Long-term Pleiotropic Effect Upon Nitric Oxide and C-Reactive Protein Levels in Patients With Peripheral Arterial Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2009

Interventions

  • Drug: Atorvastatin
    • Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
  • Drug: Standard Medical Treatment
    • Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment.

Arms, Groups and Cohorts

  • Experimental: Atorvastatin
    • Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
  • Active Comparator: Control
    • Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment

Clinical Trial Outcome Measures

Primary Measures

  • High-sensitivity C-Reactive Protein (hsCRP) and nitrites plasma levels at baseline and after one month and one year of inclusion.
    • Time Frame: Baseline and after one month and one year of inclusion.

Secondary Measures

  • Lipid profile
    • Time Frame: baseline and after one month and one year of inclusion.

Participating in This Clinical Trial

Inclusion Criteria

  • patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound) – over 18 years old Exclusion Criteria:

  • patients had previously undergone revascularization – patients were receiving treatment with statins – patients with contraindications to statin use. – patients with coexistence of chronic inflammatory diseases or steroidal medication

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Universitario Getafe
  • Provider of Information About this Clinical Study
    • Joaquin de Haro, M.D., Hospital Universitario Getafe
  • Overall Official(s)
    • Joaquin De Haro, M.D., Principal Investigator, Hospital Universitario Getafe

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.