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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario Getafe
ClinicalTrials.gov Identifier:
NCT01041729
First received: December 31, 2009
Last updated: January 4, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Drug: Atorvastatin
Drug: Standard Medical Treatment
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Getafe:

Primary Outcome Measures:
  • High-sensitivity C-Reactive Protein (hsCRP) and nitrites plasma levels at baseline and after one month and one year of inclusion. [ Time Frame: Baseline and after one month and one year of inclusion. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lipid profile [ Time Frame: baseline and after one month and one year of inclusion. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
Drug: Atorvastatin
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
Active Comparator: Control

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

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

Standard Medical Treatment.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041729

Locations
Spain
Hospital Universitario Getafe
Getafe, Madrid, Spain, 28905
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
Principal Investigator: Joaquin De Haro, M.D. Hospital Universitario Getafe
  More Information

No publications provided

Responsible Party: Joaquin de Haro, M.D., Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01041729     History of Changes
Other Study ID Numbers: STA-2009 NO-CRP
Study First Received: December 31, 2009
Last Updated: January 4, 2010
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014