Ranolazine Among Unrevascularized Chronic Stable Angina Patients (IMWELL)
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| ClinicalTrials.gov Identifier: NCT02265796 |
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Recruitment Status :
Completed
First Posted : October 16, 2014
Results First Posted : December 4, 2017
Last Update Posted : August 22, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Angina | Drug: Ranolazine Drug: Sugar pill | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Improvement of Subjective Well-Being by Ranolazine Among Unrevascularized Chronic Stable Coronary Artery Disease Patients |
| Study Start Date : | September 2014 |
| Actual Primary Completion Date : | May 2016 |
| Actual Study Completion Date : | September 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Ranolazine
Ranolazine 500 mg tablets
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Drug: Ranolazine
Ranolazine 500mg tablet
Other Name: Ranexa |
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Placebo Comparator: Sugar pill
Sugar pill that looks like the drug ranolazine 500mg tablet
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Drug: Sugar pill
Other Name: placebo |
- 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).
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- Subjective Well Being [ Time Frame: Compare from baseline to month 4 ]overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4
- Ischemia Driven Revascularization or Hospitalization [ Time Frame: 4 month ]Number of participants who reported adverse events for ischemia driven revascularization or hospitalization
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265796
| United States, Florida | |
| North Florida/South Georgia Veterans Health System | |
| Gainesville, Florida, United States, 32608 | |
| Principal Investigator: | Anthony A Bavry, MD, MPH | NorthFlorida/South Georgia Veterans Health System, Gainesville, FL 32608 |
| Responsible Party: | Anthony A Bavry, Interventional Cardiologist, North Florida Foundation for Research and Education |
| ClinicalTrials.gov Identifier: | NCT02265796 |
| Other Study ID Numbers: |
149-2013 |
| First Posted: | October 16, 2014 Key Record Dates |
| Results First Posted: | December 4, 2017 |
| Last Update Posted: | August 22, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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deferred percutaneous coronary intervention fractional flow reserve |
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Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain |
Pain Neurologic Manifestations Ranolazine Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |