AnginaPhase 2IMWELL3NCT02147834
Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents
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
To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable 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
- 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 insufficience (i.e. creatinine clearance < 30mL/min/1.73 m2)
- QTc > 500 milliseconds
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: Effect of Ranolazine After Deferral of Percutaneous Coronary Intervention by Fractional Flow Reserve (IMWELL3)
To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.
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 patients who are deferred from having a PCI based on the FFR measurement.
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.
Two month phone calls will be made to determine well being and adverse events.
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
Subjects will take the study medication for 16 weeks and will receive a phone call from the study coordinator 30 days after last dose of study medication.
- 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
sugar pill manufactured to mimic ranolazine 500mg tablet
- 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 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: 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 Month 4
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).
Measured: Change in baseline to month 4
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
frequency of the number of 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 posted28 May 2014 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionSep 2016
Why it stopped: due to futility
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 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida Foundation for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, University of Florida
- Responsible party
- Sponsor
- Investigators
- Anthony A Bavry, MD, MPH, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147834
- Sponsor's protocol ID
- 201400100
- Acronym
- IMWELL3
- Status last verified
- May 2019
- First submitted
- 22 May 2014
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ranolazine After Deferral of Percutaneous Coronary Intervention by Fractional Flow Reserve (IMWELL3)
- ClinicalTrials.gov ID
- NCT02147834
- Acronym / sponsor ID
- IMWELL3 / 201400100
- Conditions
- Angina
- Keywords
- deferred percutaneous coronary intervention, fractional flow reserve
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to futility
- Enrolment
- 5 participants (actual)
- Lead sponsor
- North Florida Foundation for Research and EducationUniversity, hospital or other
- Collaborators
- Gilead Sciences, University of Florida
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 11 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if ranolazine improves angina symptoms at 4 months compared with placebo among patients who are deferred for receiving a Percutaneous Coronary Intervention (PCI) based on the Fractional Flow Reserve (FFR) measurement.
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 patients who are deferred from having a PCI based on the FFR measurement.
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.
Two month phone calls will be made to determine well being and adverse events.
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
Subjects will take the study medication for 16 weeks and will receive a phone call from the study coordinator 30 days after last dose of study medication.
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 | Active comparator | Drug: RanolazineRanolazine 500mg tablet 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 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable 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
- 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
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: placebosugar pill manufactured to mimic 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 | Drug | Sugar pill |
Primary outcome
Seattle Angina Questionnaire Score Change From Baseline to Month 4
Time frame: Change in baseline to month 4
The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease (physical limitation, anginal stability, anginal frequency, treatment satisfaction, and disease perception).
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 11 Jun 2019.
- 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.
Anthony A Bavry, MD, MPH principal investigator
North Florida/South Georgia Veterans Health System
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 2 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: stopped early, as of the sponsor's last update on 11 Jun 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 11 Jun 2019). 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 Month 4 (time frame: Change in baseline to month 4). 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 11 Jun 2019.