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

Peripheral Arterial Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041729
• Other study ID #: STA-2009 NO-CRP
• Status: Completed
• Phase: Phase 4
• First received: December 31, 2009
• Last updated: January 4, 2010
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: December 2009
• Source: Hospital Universitario Getafe
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Atorvastatin
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
• Standard Medical Treatment
Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment.

Locations

Country	Name	City	State
Spain	Hospital Universitario Getafe	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Lipid profile		baseline and after one month and one year of inclusion.	No