Status:
COMPLETED
ARREST PAD (Peripheral Arterial Disease)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Arterial Occlusive Disease
Intermittent Claudication
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
PHASE3
Brief Summary
This trial will test the hypothesis that inflammation and insulin resistance contribute to reduced walking distance in subjects with intermittent claudication by impairing vascular reactivity and skel...
Detailed Description
People with peripheral arterial disease (PAD), an important clinical manifestation of atherosclerosis, often suffer symptoms of intermittent claudication that impair their walking ability and adversel...
Eligibility Criteria
Inclusion
- symptomatic intermittent claudication for \>= 6 months
- resting ankle/brachial index (ABI) \<=0.90
- maximal treadmill walking time between 1-20 minutes
- \>= 20% decrease in ABI post treadmill exercise
- 4 week statin wash-out prior to initial study testing (if applicable)
Exclusion
- myocardial infarction or coronary artery bypass surgery within past 6 months
- lower extremity revascularization (surgical or percutaneous) within past 6 months
- transient ischemic attack or ischemic stroke within past 6 months
- pregnancy
- uncontrolled hypertension (systolic pressure \> 180mmHg and/or diastolic pressure \> 100mmHg
- serum creatinine \>2.5
- hepatic transaminases (AST, ALT) \> 3x upper limit of normal (ULN)
- creatine kinase \> 5x ULN
- known hypersensitivity to HMG-CoA reductase inhibitors
- insulin dependent Type 2 diabetes
- current treatment with thiazolidinedione
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00153166
Start Date
January 1 2004
End Date
December 1 2011
Last Update
September 30 2014
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115