Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities (STERILE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities. THE STERILE TRIAL.|
- absolute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- ischemic walking distance, absolute walking distance and rest/exercise ABI from completion of 12 week supervised exercise program to study termination [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- major adverse cardiovascular events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2009|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Exercise + Ranolazine
This group will participate in the 12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth.
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Other Name: Ranexa
Placebo Comparator: Exercise + sugar pill
This group will participate in the 12 week supervised exercise regimen and will receive a placebo in place of the study drug.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00914316
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Laura Franny, M.D.||William Beaumont Hospitals|