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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
History of Changes
  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:

U.S. FDA Resources

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
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013