Chronic Stable AnginaPhase 4EREDANCT01948310
Effects of Ranolazine and Exercise on Daily Physical Activity Trial
A Phase 4 study testing Ranolazine and Aerobic Exercise in people with Chronic Stable Angina, run by Duke University at 1 site in United States.
Trial summary
The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Stable Angina
- What is being tested?
- Ranolazine and Aerobic Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 10 Oct 2016
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented CAD diagnosis
- Stable angina ≥ 3 months
Who cannot join
- Class III or IV heart failure
- Myocardial Infarction or coronary revascularization procedure within 2 months
- QT interval > 500ms or prescribed medication known to prolong the QTc interval
- Contraindicated Medications
- Metformin dose > 1700mg/day
- Class Ia, Ic and III anti-arrhythmics
Show all 12Show fewer
- CYP3A inhibitors
- Simvastatin >20mg/day
- Severe renal disease (< 30ml/min creatinine clearance)
- Currently on dialysis
- Lack of transportation to the exercise and testing facilities
- Implanted pacemaker that is not rate responsive
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living
Durham, North Carolina, 27710
About this study
The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.
- Conditions
- Chronic Stable Angina
- Being tested
- Ranolazine, Aerobic Exercise, Placebo
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Renexa
Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
Aerobic ExerciseBehavioural
Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
PlaceboDrug
Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine plus Exercise | Active comparator | Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. Receives: Drug: Ranolazine; Behavioral: Aerobic Exercise |
| Placebo plus Exercise | Placebo comparator | Placebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. Receives: Behavioral: Aerobic Exercise; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Consumption (VO2 Max)
This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.
Measured: Baseline, Week 2 and Week 14
Secondary outcomes (2)
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire
The Treatment Satisfaction scale is one of five scales of the Seattle Angina Questionnaire. The possible range of scores is 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, Week 2 and Week 14
Change in Total Daily Energy Expenditure
Total daily physical activity is measured via Actigraph GT3X accelerometers. Accelerometers will be worn for 7 days pre-drug, post-drug/pre-exercise (week 4) and again in the final month of the exercise intervention (week 13)
Measured: Week 1, Week 4 and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startDec 2013
- Primary completion10 Oct 2016
- Study completion10 Oct 2016
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 Chronic Stable AnginaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- William E Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948310
- Sponsor's protocol ID
- Pro00045794
- Acronym
- EREDA
- Status last verified
- Nov 2017
- First submitted
- 17 Sep 2013
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ranolazine and Exercise on Daily Physical Activity Trial
- ClinicalTrials.gov ID
- NCT01948310
- Acronym / sponsor ID
- EREDA / Pro00045794
- Conditions
- Chronic Stable Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Dec 2013
- Primary completion
- 10 Oct 2016 (actual)
- Study completion
- 10 Oct 2016 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess whether the increased angina threshold on ranolazine and subsequent higher training intensity will result in improved exercise tolerance and oxygen consumption; and greater than that observed with exercise training on placebo. The study team anticipates the chronic exercise improvements with ranolazine will be incrementally higher than the acute effects provided by ranolazine alone and demonstrated in previous trials. Key secondary objectives include the acute ranolazine and chronic exercise plus ranolazine effects on total daily energy expenditure (TDEE) and angina-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine plus Exercise | Active comparator | Drug: Ranolazine, Behavioral: Aerobic ExerciseRanolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. |
| Placebo plus Exercise | Placebo comparator | Behavioral: Aerobic Exercise, Drug: PlaceboPlacebo pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Documented CAD diagnosis
- Stable angina ≥ 3 months
Key exclusion criteria (12 listed)
- Class III or IV heart failure
- Myocardial Infarction or coronary revascularization procedure within 2 months
- QT interval > 500ms or prescribed medication known to prolong the QTc interval
- Contraindicated Medications
- Metformin dose > 1700mg/day
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: RenexaComparison of Ranolazine 1000mg twice per day versus placebo twice per day | Drug | Ranolazine plus Exercise |
| Aerobic ExerciseAerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test) | Behavioural | Placebo plus Exercise, Ranolazine plus Exercise |
| PlaceboComparison of placebo twice per day vs. Ranolazine 1000mg twice per day | Drug | Placebo plus Exercise |
Primary outcome
Change in Peak Oxygen Consumption (VO2 Max)
Time frame: Baseline, Week 2 and Week 14
This test involves exercising on a treadmill or bike to maximal exertion, during which the subject's breathing and oxygen consumption are measured. Under a set study protocol, treadmill or bike workload will increase every minute until the participant either chooses to end the test or the study personnel choose to end the test for safety purposes.
2 secondary outcomes
Change in Treatment Satisfaction as Measured by the Seattle Angina Questionnaire
Time frame: Baseline, Week 2 and Week 14
Change in Total Daily Energy Expenditure
Time frame: Week 1, Week 4 and Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William E Kraus, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine and Aerobic Exercise in people with Chronic Stable Angina, run by Duke University 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 12 Dec 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 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?
Change in Peak Oxygen Consumption (VO2 Max) (time frame: Baseline, Week 2 and Week 14). 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 12 Dec 2017.