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
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Drug: Ranolazine
Drug: Placebo

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • absolute walking distance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: May 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Ranolazine
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.
Drug: Placebo
twice daily

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914316

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Laura Franny, M.D. William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Laura Franey, investigator and responsible party, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00914316     History of Changes
Other Study ID Numbers: 2009-051
Study First Received: June 2, 2009
Last Updated: May 21, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Lower leg claudication
Poor circulation of the leg muscles
Cramping or discomfort in the lower legs
Lower leg pain
Peripheral arterial disease
PAD

Additional relevant MeSH terms:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014