ARREST PAD (Peripheral Arterial Disease)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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 skeletal muscle metabolic function.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Atorvastatin; Atorvastatin Calcium; Pioglitazone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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