Phase 3 N=76 Randomized Quadruple-blind Treatment

ARREST PAD (Peripheral Arterial Disease)

Arterial Occlusive Disease · Intermittent Claudication · Insulin Resistance

Bottom Line

View on ClinicalTrials.gov: NCT00153166 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Lower Extremity Skeletal Muscle Glucose Uptake — 62.9; 48.6; 49.5 umol/kg/min

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: atorvastatin and pioglitazone (Drug); atorvastatin/placebo (Drug); pioglitazone/placebo (Drug); placebo/placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Lower Extremity Skeletal Muscle Glucose Uptake	62.9; 48.6; 49.5	—
SECONDARY 'M' = Whole Body Insulin Sensitivity	5.0; 3.4; 3.4	—

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.

Eligibility Criteria

Inclusion Criteria

symptomatic intermittent claudication for >= 6 months
resting ankle/brachial index (ABI) = 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00153166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.