Status:
UNKNOWN
Multifactorial Intervention on Cardiovascular Risk Factors in Subjects With Peripheral Arterial Disease
Lead Sponsor:
Hospital de Sabadell
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Peripheral Arterial Disease
Hypercholesterolemia
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to evaluate whether an intensified multifactorial intervention program about cardiovascular risk factors in subjects with peripheral arterial disease (with and without di...
Detailed Description
Subjects with peripheral arterial disease show an increased cardiovascular risk. It is thought that improving control of cardiovascular risk factors (hypercholesterolemia, hypertension, diabetes, smok...
Eligibility Criteria
Inclusion
- Arm-ankle index \< 0.85 and \> 0.40 in at least one leg
Exclusion
- Advanced peripheral arterial disease (arm-ankle index \< 0.40 or amputation)
- Peripheral arterial disease of non-atherosclerotic origin (e.g. vasculitis)
- Heart failure (NYHA III or IV)
- End-stage renal disease
- Atrial fibrillation
- Active peptic ulcer disease
- Blood coagulation disorders
- Platelets disorders
- Cancer
- History of rhabdomyolysis
- Treatment with immunosuppressant agents (e.g. cyclosporine, glucocorticoids)
- Excessive intake of alcohol (\> 280 gr/week)
- Institutionalized patients
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00144937
Start Date
March 1 2003
End Date
August 1 2005
Last Update
September 5 2005
Active Locations (1)
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1
Hospital de Sabadell
Sabadell, Barcelona, Spain, 08208