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

Primary Purpose

Peripheral Arterial Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Lower leg claudication, Poor circulation of the leg muscles, Cramping or discomfort in the lower legs, Lower leg pain, PAD (Peripheral arterial disease)

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Phase 1-Ranolazine, Phase 2-Ranolazine

Phase 1 -Ranolazine, Phase 2 -Placebo

Phase 1 -Placebo, Phase 2 -Ranolazine

Phase 1 -Placebo, Phase 2 -Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage Increase in Absolute Walking Distance Following Phase 1
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
Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test

Full Information

First Posted
June 2, 2009
Last Updated
July 10, 2017
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00914316
Brief Title
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
Acronym
STERILE
Official Title
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities. THE STERILE TRIAL.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Lower leg claudication, Poor circulation of the leg muscles, Cramping or discomfort in the lower legs, Lower leg pain, PAD (Peripheral arterial disease)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1-Ranolazine, Phase 2-Ranolazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phase 1 -Ranolazine, Phase 2 -Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phase 1 -Placebo, Phase 2 -Ranolazine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phase 1 -Placebo, Phase 2 -Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
twice daily
Primary Outcome Measure Information:
Title
Percentage Increase in Absolute Walking Distance Following Phase 1
Description
Change in absolute walking distance in meters from baseline to 12 week follow-up treadmill test, as a percentage from baseline treadmill test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage Increase in Absolute Walking Distance Following Phase 2
Description
Change in absolute walking distance in meters from baseline to 24 week follow-up treadmill test, as a percentage from baseline treadmill test
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Franny, M.D.
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data

Learn more about this trial

Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

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