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Completed

NCT Number: NCT01041729

Long-term Pleiotropic Effect of Statins 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Getafe

Getafe, Madrid, 28905, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months

Standard Medical Treatment

Drug

Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months.

Standard Medical Treatment.

Primary outcomes

  1. 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 outcomes

  1. Lipid profile

    Time frame: baseline and after one month and one year of inclusion.

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Sponsors and collaborators

Lead sponsor

Hospital Universitario Getafe

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 1, 2010
Registry last updated
Jan 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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