ARREST PAD (Peripheral Arterial Disease)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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People with peripheral arterial disease (PAD), an important clinical manifestation of atherosclerosis, often suffer symptoms of intermittent claudication that impair their walking ability and adversely affect their quality of life. People with PAD are also at increased risk for adverse cardiovascular events, including myocardial infarction, stroke and death. Unfortunately, medical therapies directed to the functional and limb-threatening manifestations are limited. Little attention has been paid to the biologic processes that cause PAD, and to atherogenic mechanisms that may preferentially affect the peripheral circulation.

Vascular inflammation and insulin resistance are two important and interdependent conditions that are associated with atherosclerosis. Subjects in this trial (160 adults with stable intermittent claudication who are not taking insulin or insulin-sensitizing medications, such as thiazolidinediones) will be randomized in a placebo-controlled, parallel design manner, to atorvastatin 80 mg orally daily (to reduce inflammation) and pioglitazone 45 mg orally once daily (to improve insulin sensitivity). Forty healthy adult subjects, age and gender-matched to a subset of the study group, will be enrolled to serve as a control population. Primary and secondary study endpoints include: treadmill walking time, endothelium-dependent vasodilation, and insulin-mediated skeletal muscle glucose uptake.

Conditions

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Arterial Occlusive Disease Intermittent Claudication Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Patients with PAD (Including diabetics)

Randomized to either atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, or placebo/placebo.

Group Type EXPERIMENTAL

atorvastatin and pioglitazone

Intervention Type DRUG

atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)

atorvastatin/placebo

Intervention Type DRUG

atorvastatin 80 mg orally once daily and matching placebo orally twice daily

pioglitazone/placebo

Intervention Type DRUG

pioglitazone 30 mg orally once daily and matching placebo orally once daily

placebo/placebo

Intervention Type DRUG

placebo orally three times daily

PAD (Excluding Diabetics)

Randomized to either atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, or placebo/placebo.

Group Type ACTIVE_COMPARATOR

atorvastatin and pioglitazone

Intervention Type DRUG

atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)

atorvastatin/placebo

Intervention Type DRUG

atorvastatin 80 mg orally once daily and matching placebo orally twice daily

pioglitazone/placebo

Intervention Type DRUG

pioglitazone 30 mg orally once daily and matching placebo orally once daily

placebo/placebo

Intervention Type DRUG

placebo orally three times daily

Healthy Controls

Randomized to either atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, or placebo/placebo.

Group Type ACTIVE_COMPARATOR

atorvastatin and pioglitazone

Intervention Type DRUG

atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)

atorvastatin/placebo

Intervention Type DRUG

atorvastatin 80 mg orally once daily and matching placebo orally twice daily

pioglitazone/placebo

Intervention Type DRUG

pioglitazone 30 mg orally once daily and matching placebo orally once daily

placebo/placebo

Intervention Type DRUG

placebo orally three times daily

Interventions

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atorvastatin and pioglitazone

atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity)

Intervention Type DRUG

atorvastatin/placebo

atorvastatin 80 mg orally once daily and matching placebo orally twice daily

Intervention Type DRUG

pioglitazone/placebo

pioglitazone 30 mg orally once daily and matching placebo orally once daily

Intervention Type DRUG

placebo/placebo

placebo orally three times daily

Intervention Type DRUG

Other Intervention Names

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atorvastatin: lipitor pioglitazone: actos atorvastatin: lipitor pioglitazone: actos

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes