At a glance
ClinicalIndex Comparison Record- ✓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 immediately post-exercise on treadmill
- ✕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
- ✕Uncontrolled hypertension: systolic >180 mmHg and/or diastolic >100 mmHg
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Contribution of Inflammation and Insulin Resistance to Intermittent Claudication
In Brief
A Phase 3 clinical trial evaluating atorvastatin and pioglitazone, atorvastatin/placebo, and 2 other interventions for Arterial Occlusive Disease and 2 related conditions. Completed, enrolled 76 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)
atorvastatin 80 mg orally once daily and matching placebo orally twice daily
pioglitazone 30 mg orally once daily and matching placebo orally once daily
placebo orally three times daily