Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities

NCT ID: NCT00914316

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-03-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

Ranolazine, 1000 mg, capsule, twice daily, by mouth.

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.

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

Ranolazine, 1000 mg, capsule, twice daily, by mouth.

Placebo

Intervention Type: DRUG

twice daily

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.

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

Ranolazine, 1000 mg, capsule, twice daily, by mouth.

Placebo

Intervention Type: DRUG

twice daily

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

twice daily

Interventions

Ranolazine

Ranolazine, 1000 mg, capsule, twice daily, by mouth.

Intervention Type: DRUG

Placebo

twice daily

Intervention Type: DRUG

Other Intervention Names

Ranexa; sugar pill

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

William Beaumont Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Franny, M.D.

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2009-051

Identifier Type: -

Identifier Source: org_study_id