AnginaPhase 2IMWELLNCT02265796
Ranolazine Among Unrevascularized Chronic Stable Angina Patients
A Phase 2 study testing Ranolazine and Sugar pill in people with Angina, run by North Florida Foundation for Research and Education at 1 site in United States.
Trial summary
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina
- What is being tested?
- Ranolazine and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2016
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
- At least 1 indeterminate stenosis (20-80%),
- Fractional flow reserve (FFR) <=0.8 and PCI deferred
Who cannot join
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
- acute coronary syndrome or cardiogenic shock
- QTc > 500 milliseconds
- use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
- use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
- liver cirrhosis
- sever renal insufficiency (i.e. creatinine clearance < 30mL/min/1.73 m2)
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Improvement of Subjective Well-Being by Ranolazine Among Unrevascularized Chronic Stable Coronary Artery Disease Patients
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization
Read the detailed description
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization.
Baseline Procedure:
Assessments performed exclusively to determine eligibility for this study would be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. The assessment will include:
- Informed Consent
- Review subject eligibility criteria
- FFR value calculated at the time of cardiac catheterization
- Review previous and concomitant medications
- Frequency of symptoms and quality of life prior to study according to Seattle Angina Questionnaire (SAQ)
Screening Visit:
The assessments to determine eligibility are:
- Review of eligibility criteria
- Review of cardiac catheterization and FFR
- Review of medications taken in the past 30 days Subjects that meet eligibility criteria will be randomized to receive either the active drug, Ranolazine or a matching placebo (non-active drug). Staff and subjects will not know if the subject will be receiving the active drug or the placebo.
Drug schedule will be as follows:
- 1st dose of one tablet (500mg) will begin the evening of Day 1
- On Days 2-7, one tablet (500mg) two times a day (12-hours apart).
- On Day 8, increase dose of study drug to two tablets (1000mg) twice a day; once in the morning and once in the evening, 12 hours apart. This dose will continue for the duration of the study. The study drug can be taken with or without food.
Telephone Follow-up:
One week phone calls will be made to determine well being, adverse events, answer questions and remind subjects to increase the study medication dose.
Month 4 Follow-up:
- Frequency of symptoms and quality of life according to Seattle Angina Questionnaire (SAQ)
- Assessment of well-being
- Any hospitalizations or the need for revascularization
- Conditions
- Angina
- Being tested
- Ranolazine, Sugar pill
- Keywords
- deferred percutaneous coronary intervention, fractional flow reserve
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
Ranolazine 500mg tablet
- 500mg tablet two times per day for 7 days then,
- 500mg tablet (1000mg) two times per day for 15 weeks
Sugar pillDrug
Also called placebo
- 500mg tablet two times per day for 7 days then,
- 500mg tablet (1000mg) two times per day for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Active comparator | Ranolazine 500 mg tablets
1. 500mg tablet two times per day for 7 days then,
2. 500mg tablet (1000mg) two times per day for 15 weeks Receives: Drug: Ranolazine |
| Sugar pill | Placebo comparator | Sugar pill that looks like the drug ranolazine 500mg tablet
1. 500mg tablet two times per day for 7 days then,
2. 500mg tablet (1000mg) two times per day for 15 weeks Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated.
Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
.
Measured: Change in baseline to 16 weeks
Secondary outcomes (2)
Subjective Well Being
overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4
Measured: Compare from baseline to month 4
Ischemia Driven Revascularization or Hospitalization
Number of participants who reported adverse events for ischemia driven revascularization or hospitalization
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnginaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida Foundation for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Anthony A Bavry, North Florida Foundation for Research and Education
- Investigators
- Anthony A Bavry, MD, MPH, Principal investigator, NorthFlorida/South Georgia Veterans Health System, Gainesville, FL 32608
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265796
- Sponsor's protocol ID
- 149-2013
- Acronym
- IMWELL
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2014
- Last updated
- 22 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bavry AA, Park KE, Choi CY, Mahmoud AN, Wen X, Elgendy IY. Improvement of Subjective Well-Being by Ranolazine in Patients with Chronic Angina and Known Myocardial Ischemia (IMWELL Study). Cardiol Ther. 2017 Jun;6(1):81-88. doi: 10.1007/s40119-016-0081-3. Epub 2017 Jan 2.
PubMed 28044265
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Subjective Well-Being by Ranolazine Among Unrevascularized Chronic Stable Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT02265796
- Acronym / sponsor ID
- IMWELL / 149-2013
- Conditions
- Angina
- Keywords
- deferred percutaneous coronary intervention, fractional flow reserve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- North Florida Foundation for Research and EducationUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Oct 2014 (estimated)
- Results
- Posted 4 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization
Detailed description
This is a prospective, double-blind, placebo-controlled, randomized, single-center (North Florida- South Georgia VA Medical Center) study. The study objective is to determine if ranolazine improves angina symptoms at 4 months compared with placebo among stable coronary artery disease patients who have demonstrable myocardial ischemia, but who do not undergo revascularization.
Baseline Procedure:
Assessments performed exclusively to determine eligibility for this study would be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. The assessment will include:
- Informed Consent
- Review subject eligibility criteria
- FFR value calculated at the time of cardiac catheterization
- Review previous and concomitant medications
- Frequency of symptoms and quality of life prior to study according to Seattle Angina Questionnaire (SAQ)
Screening Visit:
The assessments to determine eligibility are:
- Review of eligibility criteria
- Review of cardiac catheterization and FFR
- Review of medications taken in the past 30 days Subjects that meet eligibility criteria will be randomized to receive either the active drug, Ranolazine or a matching placebo (non-active drug). Staff and subjects will not know if the subject will be receiving the active drug or the placebo.
Drug schedule will be as follows:
- 1st dose of one tablet (500mg) will begin the evening of Day 1
- On Days 2-7, one tablet (500mg) two times a day (12-hours apart).
- On Day 8, increase dose of study drug to two tablets (1000mg) twice a day; once in the morning and once in the evening, 12 hours apart. This dose will continue for the duration of the study. The study drug can be taken with or without food.
Telephone Follow-up:
One week phone calls will be made to determine well being, adverse events, answer questions and remind subjects to increase the study medication dose.
Month 4 Follow-up:
- Frequency of symptoms and quality of life according to Seattle Angina Questionnaire (SAQ)
- Assessment of well-being
- Any hospitalizations or the need for revascularization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Active comparator | Drug: RanolazineRanolazine 500 mg tablets 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks |
| Sugar pill | Placebo comparator | Drug: Sugar pillSugar pill that looks like the drug ranolazine 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients >= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)
- At least 1 indeterminate stenosis (20-80%),
- Fractional flow reserve (FFR) <=0.8 and PCI deferred
Key exclusion criteria (7 listed)
- Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month
- acute coronary syndrome or cardiogenic shock
- QTc > 500 milliseconds
- use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)
- use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)
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 500mg tablet 1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks | Drug | Ranolazine |
| Sugar pillAlso: placebo1. 500mg tablet two times per day for 7 days then, 2. 500mg tablet (1000mg) two times per day for 15 weeks | Drug | Sugar pill |
Primary outcome
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks
Time frame: Change in baseline to 16 weeks
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life.Each of the 5 dimensions are scored by assigning eachresponse an ordinal value, beginning with 1 for the response that implies the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range1 / 3 Seattle Angina Questionnaire (SAQ)of the scale and multiplying by 100. No overall scale score is generated. Factors and Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life). .
2 secondary outcomes
Subjective Well Being
Time frame: Compare from baseline to month 4
Ischemia Driven Revascularization or Hospitalization
Time frame: 4 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28044265Bavry AA, Park KE, Choi CY, Mahmoud AN, Wen X, Elgendy IY. Improvement of Subjective Well-Being by Ranolazine in Patients with Chronic Angina and Known Myocardial Ischemia (IMWELL Study). Cardiol Ther. 2017 Jun;6(1):81-88. doi: 10.1007/s40119-016-0081-3. Epub 2017 Jan 2.
- Individual participant dataSharing planned: No
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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.
Anthony A Bavry, MD, MPH principal investigator
NorthFlorida/South Georgia Veterans Health System, Gainesville, FL 32608
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranolazine and Sugar pill in people with Angina, run by North Florida Foundation for Research and Education 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 7 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 22 Aug 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 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?
Seattle Angina Questionnaire Score Change From Baseline to 16 Weeks (time frame: Change in baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02265796, which also lists 1 linked publication.
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 22 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.