Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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 exercise alone in patients with stable claudication. Investigators also seek to determine if the administration of ranolazine provides a sustained benefit after the completion of a supervised exercise regimen. Lastly, investigators wish to determine whether both exercise and ranolazine improves peak oxygen consumption and anaerobic threshold in patients with stable claudication.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Beaumont Hospitals
• Treatments: Ranolazine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.