Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities
| Status: | Archived |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2009 |
| End Date: | May 2011 |
Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities. THE STERILE TRIAL.
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.
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.
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