Peripheral Arterial Disease
Conditions
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.
Interventions
DRUGAtorvastatin
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
DRUGStandard Medical Treatment
Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment.
Sponsors
Hospital Universitario Getafe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Lipid profile | baseline and after one month and one year of inclusion. |
Countries
Spain
Outcome results
None listed