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Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities

Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Peripheral Arterial Disease

Intervention: Ranolazine (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: William Beaumont Hospitals

Official(s) and/or principal investigator(s):
Laura Franny, M.D., Principal Investigator, Affiliation: William Beaumont Hospitals

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.

Clinical Details

Official title: Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities. THE STERILE TRIAL.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: absolute walking distance

Secondary outcome:

Secondary endpoints include: change in ischemic walking distance, rest & exercise ABI's, VO2 peak, anaerobic threshold, respiratory exchange ratio and claudication index scores from baseline to completion of 12 week supervised exercise program.

ischemic walking distance, absolute walking distance and rest/exercise ABI from completion of 12 week supervised exercise program to study termination

major adverse cardiovascular events

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 week supervised exercise program and placebo. After the 12 week supervised exercise program, all participants will undergo a second randomization to ranolazine or placebo for an additional 12 weeks, during which independent walking will be encouraged. Both groups will participate in a two week lead-in period after each randomization of the trial, allowing for the stabilization of their medications and dosing of ranolazine. Medications such as cilostazol, calcium channel blockers and nitrates will be discontinued during the lead-in period, unless their use is for management for your high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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.

- 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 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.

Locations and Contacts

William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Additional Information

Starting date: May 2009
Last updated: May 21, 2013

Page last updated: August 23, 2015

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