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

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

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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