Peripheral Arterial DiseaseSTERILENCT00914316
Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities
A study testing Ranolazine in people with Peripheral Arterial Disease, run by Corewell Health East at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities. THE STERILE TRIAL.
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.
Read the detailed description
The treatment groups are:
- Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth.
- 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
- Being tested
- Ranolazine, Placebo
- Keywords
- Lower leg claudication, Poor circulation of the leg muscles, Cramping or discomfort in the lower legs, Lower leg pain, PAD (Peripheral arterial disease)
- Medical subject headings
- Peripheral Arterial Disease, Spasm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
Ranolazine, 1000 mg, capsule, twice daily, by mouth.
PlaceboDrug
Also called sugar pill
twice daily
| Study group | Role | What they receive |
|---|---|---|
| Phase 1-Ranolazine, Phase 2-Ranolazine | Active comparator | 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. Receives: Drug: Ranolazine |
| Phase 1 -Ranolazine, Phase 2 -Placebo | Active comparator | 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. Receives: Drug: Ranolazine; Drug: Placebo |
| Phase 1 -Placebo, Phase 2 -Ranolazine | Active comparator | 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. Receives: Drug: Ranolazine; Drug: Placebo |
| Phase 1 -Placebo, Phase 2 -Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Franny, M.D., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914316
- Sponsor's protocol ID
- 2009-051
- Acronym
- STERILE
- Status last verified
- Jun 2017
- First submitted
- 2 Jun 2009
- Last updated
- 9 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Treadmill Exercise and Ranolazine for Intermittent Claudication of Lower Extremities. THE STERILE TRIAL.
- ClinicalTrials.gov ID
- NCT00914316
- Acronym / sponsor ID
- STERILE / 2009-051
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 9 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Group A will be randomized to a 12 week supervised exercise program and ranolazine, (Ranexa) 1000 mg orally, twice daily, by mouth.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1-Ranolazine, Phase 2-Ranolazine | Active comparator | Drug: RanolazineThis 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. |
| Phase 1 -Ranolazine, Phase 2 -Placebo | Active comparator | Drug: Ranolazine, Drug: PlaceboThis 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. |
| Phase 1 -Placebo, Phase 2 -Ranolazine | Active comparator | Drug: Ranolazine, Drug: PlaceboThis 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. |
| Phase 1 -Placebo, Phase 2 -Placebo | Placebo comparator | Drug: PlaceboThis 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: RanexaRanolazine, 1000 mg, capsule, twice daily, by mouth. | Drug | Phase 1 -Placebo, Phase 2 -Ranolazine, Phase 1 -Ranolazine, Phase 2 -Placebo, Phase 1-Ranolazine, Phase 2-Ranolazine |
| PlaceboAlso: sugar pilltwice daily | Drug | Phase 1 -Placebo, Phase 2 -Placebo, Phase 1 -Placebo, Phase 2 -Ranolazine, Phase 1 -Ranolazine, Phase 2 -Placebo |
Primary outcome
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
1 secondary outcome
Percentage Increase in Absolute Walking Distance Following Phase 2
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Franny, M.D. principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranolazine in people with Peripheral Arterial Disease, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Increase in Absolute Walking Distance Following Phase 1 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.