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

NCT01041729 | Completed Phase 4

• 1 other identifier: STA-2009 NO-CRP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lipid profile

  baseline and after one month and one year of inclusion.

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months

Drug: Atorvastatin

Control

ACTIVE COMPARATOR

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

Drug: Standard Medical Treatment

Interventions

Atorvastatin DRUG

Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months

Atorvastatin

Standard Medical Treatment DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients at the time of diagnosis of Fontaine grade II peripheral arterial disease (PAD), confirmed by hemodynamic evaluation (Doppler ultrasound)
• over 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (1)

Hospital Universitario Getafe

Getafe, Madrid, 28905, Spain

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Joaquin De Haro, M.D.

  Hospital Universitario Getafe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 31, 2009
• First Posted: January 1, 2010
• Study Start: January 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 5, 2010

Record last verified: 2009-12

Locations

ES (1)