Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities

Peripheral Arterial Disease Clinical Trial

— STERILE  

Official title:

Supervised Treadmill Exercise And Ranolazine For Intermittent Claudication Of Lower Extremities. THE STERILE TRIAL.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914316
• Other study ID #: 2009-051
• Status: Completed
• Phase: N/A
• First received: June 2, 2009
• Last updated: May 21, 2013
• Start date: May 2009
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Ranolazine
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
• Placebo
twice daily

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute walking distance		12 weeks	No
Secondary	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.		12 weeks	No
Secondary	ischemic walking distance, absolute walking distance and rest/exercise ABI from completion of 12 week supervised exercise program to study termination		12 weeks	No
Secondary	major adverse cardiovascular events		6 months	Yes