Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities (STERILE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Franey, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00914316
First received: June 2, 2009
Last updated: May 21, 2013
Last verified: May 2013

June 2, 2009
May 21, 2013
May 2009
March 2013   (final data collection date for primary outcome measure)
absolute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To determine whether supervised treadmill exercise training combined with ranolazine 1000 mg twice daily provides incremental benefit in absolute walking distance compared to supervised exercise alone. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00914316 on ClinicalTrials.gov Archive Site
  • 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 ]
If ranolazine provides sustained symptomatic and/or functional benefit after completion of a structured exercise program and whether exercise improves peak oxygen use and anaerobic threshold in patients with peripheral arterial disease. [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Drug: Ranolazine
    Ranolazine, 1000 mg, capsule, twice daily, by mouth.
    Other Name: Ranexa
  • Drug: Placebo
    twice daily
  • 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.
    Intervention: Drug: Ranolazine
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00914316
2009-051
Yes
Laura Franey, William Beaumont Hospitals
William Beaumont Hospitals
Not Provided
Principal Investigator: Laura Franny, M.D. William Beaumont Hospitals
William Beaumont Hospitals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP