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

H

Hospital Universitario Getafe

Status and phase

Completed
Phase 4

Conditions

Peripheral Arterial Disease

Treatments

Drug: Atorvastatin
Drug: Standard Medical Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01041729
STA-2009 NO-CRP

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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