Back to resultsLong-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Atorvastatin
Standard Medical Treatment
Sponsored by
About this trial
This is an interventional basic science trial for Peripheral Arterial Disease
Eligibility 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
Sites / Locations
- Hospital Universitario Getafe
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Atorvastatin
Control
Arm Description
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months. Standard Medical Treatment
Outcomes
Primary Outcome Measures
High-sensitivity C-Reactive Protein (hsCRP) and nitrites plasma levels at baseline and after one month and one year of inclusion.
Secondary Outcome Measures
Lipid profile
Full Information
NCT ID
NCT01041729
First Posted
December 31, 2009
Last Updated
January 4, 2010
Sponsor
Hospital Universitario Getafe
1. Study Identification
Unique Protocol Identification Number
NCT01041729
Brief Title
Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Universitario Getafe
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months.
Standard Medical Treatment
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Patients with Peripheral Arterial Disease in Fontaine Stage II treated with Atorvastatin 40mg/day during 12 months
Intervention Type
Drug
Intervention Name(s)
Standard Medical Treatment
Intervention Description
Patients with Peripheral Arterial Disease in Fontaine Stage II without treatment with Atorvastatin 40mg/day during 12 months.
Standard Medical Treatment.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Lipid profile
Time Frame
baseline and after one month and one year of inclusion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquin De Haro, M.D.
Organizational Affiliation
Hospital Universitario Getafe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Long-term Pleiotropic Effect of Statins in Patients With Peripheral Arterial Disease
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