ARREST PAD (Peripheral Arterial Disease)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Occlusive Disease Intermittent Claudication Insulin Resistance |
Drug: atorvastatin and pioglitazone Drug: atorvastatin/placebo Drug: pioglitazone/placebo Drug: placebo/placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Contribution of Inflammation and Insulin Resistance to Intermittent Claudication |
- Pain-free and maximal treadmill walking time [ Time Frame: after 3 months of study drug intervention ] [ Designated as safety issue: No ]
- Endothelium-dependent vasodilation [ Time Frame: after 3 months of study drug intervention ] [ Designated as safety issue: No ]
- Insulin-mediated skeletal muscle glucose utilization [ Time Frame: after 3 months of study drug intervention ] [ Designated as safety issue: No ]
| Enrollment: | 113 |
| Study Start Date: | January 2004 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: atorvastatin and pioglitazone
atorvastatin 80 mg daily and pioglitazone 45 mg daily
Other Name: Lipitor, Actos
|
| Active Comparator: 2 |
Drug: atorvastatin/placebo
atorvastatin 80 mg daily and pioglitazone 45 mg daily
|
| Active Comparator: 3 |
Drug: pioglitazone/placebo
atorvastatin 80 mg daily and pioglitazone 45 mg daily
|
| Placebo Comparator: 4 |
Drug: placebo/placebo
placebo
|
Detailed Description:
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 non-diabetic adults with stable intermittent claudication) 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.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Massachusetts | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Mark Creager, M.D. | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | Mark Alan Creager, MD, Principal Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00153166 History of Changes |
| Obsolete Identifiers: | NCT00225940 |
| Other Study ID Numbers: | 2003P-001501, RO1-HL075771 |
| Study First Received: | September 8, 2005 |
| Last Updated: | July 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Brigham and Women's Hospital:
|
peripheral arterial disease intermittent claudication |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Insulin Resistance Intermittent Claudication Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Arteriosclerosis Signs and Symptoms Atherosclerosis |
Pioglitazone Atorvastatin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013