ARREST PAD (Peripheral Arterial Disease)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Arterial Occlusive Disease, Intermittent Claudication, Insulin Resistance

In brief

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 skeletal muscle metabolic function.

Key facts

Study ID

NCT00153166

Run by

Brigham and Women's Hospital

People needed

76

Starts

2004-01-01

Expected to finish

2011-12-01

Last updated by the study team

2014-09-30

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Brigham & Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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