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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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

    1. 500mg tablet two times per day for 7 days then,
    2. 500mg tablet (1000mg) two times per day for 15 weeks

  • Sugar pillDrug

    Also called placebo

    1. 500mg tablet two times per day for 7 days then,
    2. 500mg tablet (1000mg) two times per day for 15 weeks
Study groups in NCT02265796
Study groupRoleWhat they receive
RanolazineActive comparatorRanolazine 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 pillPlacebo comparatorSugar 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.

  1. 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)

  1. 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

  2. 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.

  1. First posted16 Oct 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionMay 2016
  4. Study completionSep 2016

Resources

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)
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
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

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.

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