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

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Standard Medical Treatment; Drug: Atorvastatin

• Registration Number: NCT01041729
• Lead Sponsor: Hospital Universitario Getafe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Status Verified: 2009-12
• Study First Submitted: 2009-12-31
• Study First Submitted QC: 2009-12-31
• Study First Posted: 2010-01-01
• Last Update Submitted: 2010-01-04
• Last Update Posted: 2010-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard Medical Treatment	Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment
Atorvastatin	Atorvastatin	Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Lipid profile	baseline and after one month and one year of inclusion.

Trial Locations

Locations (1)

Hospital Universitario Getafe; 🇪🇸 Getafe, Madrid, Spain