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Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities (STERILE)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914316
First Posted: June 4, 2009
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
William Beaumont Hospitals
  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
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, 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:
  • Percentage Increase in Absolute Walking Distance Following Phase 1 [ Time Frame: 12 weeks ]
    Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test


Secondary Outcome Measures:
  • Percentage Increase in Absolute Walking Distance Following Phase 2 [ Time Frame: 24 weeks ]
    Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test


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
Active Comparator: Phase 1-Ranolazine, Phase 2-Ranolazine
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Drug: Ranolazine
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Other Name: Ranexa
Active Comparator: Phase 1 -Ranolazine, Phase 2 -Placebo
This group will participate in the Phase 1 -12 week supervised exercise program and will additionally receive ranolazine 1000 mg orally, twice daily, by mouth. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Drug: Ranolazine
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Other Name: Ranexa
Drug: Placebo
twice daily
Other Name: sugar pill
Active Comparator: Phase 1 -Placebo, Phase 2 -Ranolazine
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and also receive ranolazine 1000 mg orally twice daily by mouth.
Drug: Ranolazine
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Other Name: Ranexa
Drug: Placebo
twice daily
Other Name: sugar pill
Placebo Comparator: Phase 1 -Placebo, Phase 2 -Placebo
This group will participate in the Phase 1 -12 week supervised exercise regimen and will receive a sugar pill in place of the study drug. In Phase 2, the group will exercise independently and will receive a sugar pill in place of the study drug.
Drug: Placebo
twice daily
Other Name: sugar pill

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 high blood pressure. Anti-platelet (blood thinner) medications will be continued throughout the trial.

  Eligibility

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • corrected QT interval (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 Cytochrome P450-3A (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00914316     History of Changes
Other Study ID Numbers: 2009-051
First Submitted: June 2, 2009
First Posted: June 4, 2009
Results First Submitted: April 3, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share individual participant data

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
PAD (Peripheral arterial disease)

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action