Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-03-23 @ 12:28 PM
Study NCT ID:
NCT02147834
Status:
TERMINATED
Last Update Posted:
2019-06-11
First Post:
2014-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069458', 'term': 'Ranolazine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anthony.bavry@va.gov', 'phone': '352-548-6000', 'title': 'Anthony A Bavry, M.D.', 'phoneExt': '104726', 'organization': 'North Florida South Georigai Veteran Health System'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'baseline to 4 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nRanolazine: Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks', 'otherNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sugar Pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nSugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Seattle Angina Questionnaire Score Change From Baseline to Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nRanolazine: Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nSugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}], 'timeFrame': 'Change in baseline to month 4', 'description': '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).', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigator ended this project early due to futility. Do data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Subjective Well Being', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nRanolazine: Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nSugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}], 'timeFrame': 'Compare from baseline to month 4', 'description': 'overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigator ended this study early due to futility. no data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Ischemia Driven Revascularization or Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nRanolazine: Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}, {'id': 'OG001', 'title': 'Sugar Pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nSugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}], 'timeFrame': '4 month', 'description': 'frequency of the number of reported adverse events for ischemia driven revascularization or hospitalization', 'reportingStatus': 'POSTED', 'populationDescription': 'The investigator ended this study early due to futility. No data was analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nRanolazine: Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}, {'id': 'FG001', 'title': 'Sugar Pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nSugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '5 subjects enrolled. First subjected enrolled 8/7/2015 and last enrolled on 11/19/2015. enrollment discontinued early by investigator due to futility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nRanolazine: Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}, {'id': 'BG001', 'title': 'Sugar Pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks\n\nSugar pill: sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'due to futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2014-05-22', 'resultsFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-22', 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seattle Angina Questionnaire Score Change From Baseline to Month 4', 'timeFrame': 'Change in baseline to month 4', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Subjective Well Being', 'timeFrame': 'Compare from baseline to month 4', 'description': 'overall feeling of well being determined from rating of excellent, good, fair or poor at baseline compared to same at month 4'}, {'measure': 'Ischemia Driven Revascularization or Hospitalization', 'timeFrame': '4 month', 'description': 'frequency of the number of reported adverse events for ischemia driven revascularization or hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['deferred percutaneous coronary intervention', 'fractional flow reserve'], 'conditions': ['Angina']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBaseline Procedure:\n\nAssessments 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:\n\n* Informed Consent\n* Review subject eligibility criteria\n* FFR value calculated at the time of cardiac catheterization\n* Review previous and concomitant medications\n* Frequency of symptoms and quality of life prior to study according to Seattle Angina Questionnaire (SAQ)\n\nScreening Visit:\n\nThe assessments to determine eligibility are:\n\n* Review of eligibility criteria\n* Review of cardiac catheterization and FFR\n* Review of medications taken in the past 30 days\n\nSubjects 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.\n\nDrug schedule will be as follows:\n\n* 1st dose of one tablet (500mg) will begin the evening of Day 1\n* On Days 2-7, one tablet (500mg) two times a day (12-hours apart).\n* 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.\n\nTelephone Follow-up:\n\nOne week phone calls will be made to determine well being, adverse events, answer questions and remind subjects to increase the study medication dose.\n\nTwo month phone calls will be made to determine well being and adverse events.\n\nMonth 4 Follow-up:\n\n* Frequency of symptoms and quality of life according to Seattle Angina Questionnaire (SAQ)\n* Assessment of well-being\n* Any hospitalizations or the need for revascularization\n\nSubjects 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stable patients \\>= 18 years of age referred for cardiac catheterization for evaluation of cardiac symptoms ( angina, fatigue, or shortness of breath)\n* At least 1 indeterminate stenosis (20-80%), fractional flow reserve (FFR) \\>=0.8 and PCI deferred\n\nExclusion Criteria:\n\n* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) during the index procedure or anticipated within the next month\n* acute coronary syndrome or cardiogenic shock\n* use of strong inhibitors of CTP3A (i.e. ketoconazole, itraconazole, clarithromycin,nefazodone, nelfinavir, ritonavir, indinavir and saquinavir)\n* use of inducers of CYP3A (i.e. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)\n* liver cirrhosis\n* sever renal insufficience (i.e. creatinine clearance \\< 30mL/min/1.73 m2)\n* QTc \\> 500 milliseconds"}, 'identificationModule': {'nctId': 'NCT02147834', 'acronym': 'IMWELL3', 'briefTitle': 'Effectiveness of Ranolazine on Reducing Chest Pain in Patients With Blockage But no Stents', 'organization': {'class': 'OTHER', 'fullName': 'North Florida Foundation for Research and Education'}, 'officialTitle': 'Effect of Ranolazine After Deferral of Percutaneous Coronary Intervention by Fractional Flow Reserve (IMWELL3)', 'orgStudyIdInfo': {'id': '201400100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ranolazine', 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks', 'interventionNames': ['Drug: Ranolazine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sugar pill', 'description': 'Sugar pill that looks like the drug ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks', 'interventionNames': ['Drug: Sugar pill']}], 'interventions': [{'name': 'Ranolazine', 'type': 'DRUG', 'otherNames': ['Ranexa'], 'description': 'Ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks', 'armGroupLabels': ['Ranolazine']}, {'name': 'Sugar pill', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'sugar pill manufactured to mimic ranolazine 500mg tablet\n\n1. 500mg tablet two times per day for 7 days then,\n2. 500mg tablet (1000mg) two times per day for 15 weeks', 'armGroupLabels': ['Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'North Florida/South Georgia Veterans Health System', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Anthony A Bavry, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Florida/South Georgia Veterans Health System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Florida Foundation for Research and Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': 'University of Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}