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

January 4, 2010 updated by: Hospital Universitario Getafe

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario Getafe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
Drug: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Baseline and after one month and one year of inclusion.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Getafe

Investigators

  • Principal Investigator: Joaquin De Haro, M.D., Hospital Universitario Getafe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 31, 2009

First Submitted That Met QC Criteria

December 31, 2009

First Posted (Estimate)

January 1, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2010

Last Update Submitted That Met QC Criteria

January 4, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STA-2009 NO-CRP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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