Status:
TERMINATED
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
Lead Sponsor:
Corewell Health East
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The goal of this study is to evaluate whether supervised treadmill exercise combined with ranolazine 1000 mg twice daily provides an incremental benefit in absolute walking distance over supervised ex...
Detailed Description
The treatment groups are: A. Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth. B. Group B will be randomized to a 12...
Eligibility Criteria
Inclusion
- Males or females greater than 40 years of age.
- Documented peripheral arterial disease
- Stable lower extremity intermittent claudication (Rutherford class 1-3) for 3 months.
Exclusion
- Critical limb ischemia (Rutherford class 4-6).
- Percutaneous or surgical lower extremity revascularization within last 12 months.
- Myocardial infarction within the last 6 months.
- cardiac surgery within the last 6 months.
- Unstable angina
- Stable chronic angina
- New York Heart Association Class II-IV heart failure
- Left ventricular ejection fraction less than or equal to 35%
- Venous thromboembolism within the last 6 months.
- Uncontrolled high blood pressure, defined as systolic blood pressure greater than or equal to 180 mmHg or diastolic blood pressure greater than or equal to 110 mmHg.
- Allergy to ranolazine.
- corrected QT interval (QTc) greater than or equal to 440 ms in males or 460 ms in females.
- Pregnant or nursing females.
- Chronic dialysis therapy.
- Significant liver impairment (defined as transaminases greater than or equal to 3 times the upper limit of normal) within the last 6 months.
- Concomitant use of Cytochrome P450-3A (CYP3A) inhibitors
- Concomitant use of CYP3A inducers
- QTc prolonging agents
- Orthopedic or neurologic disorders that prevent treadmill walking.
- Current participation in a structured exercise program.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00914316
Start Date
May 1 2009
End Date
March 1 2013
Last Update
August 9 2017
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073