Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT01938235
Status:
UNKNOWN
Last Update Posted:
2016-08-05
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exenatide for Myocardial Protection During Reperfusion Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, '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': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-03', 'studyFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI)', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Left ventricular global and regional LV systolic ejection fraction', 'timeFrame': '72 hours'}, {'measure': 'Left ventricular global and regional LV systolic ejection fraction', 'timeFrame': '3 months'}, {'measure': 'Left ventricular volume', 'timeFrame': '72 hours'}, {'measure': 'Left ventricular volume', 'timeFrame': '3 months'}, {'measure': 'Infarct size/area of risk (measured by cMRI)', 'timeFrame': '3 months'}, {'measure': 'Myocardial enzyme levels (troponin I and CK-MB)', 'timeFrame': '24 hours'}, {'measure': 'ST segment elevation resolution (measured by ECG)', 'timeFrame': '1 hour'}, {'measure': 'ST segment elevation resolution (measured by ECG)', 'timeFrame': '24 hours'}, {'measure': 'ST segment elevation resolution (measured by ECG)', 'timeFrame': '72 hours'}, {'measure': 'ST segment elevation resolution (measured by ECG)', 'timeFrame': '3 months'}, {'measure': 'Angiographic myocardial blush score', 'timeFrame': 'At the time of the PCI procedure'}, {'measure': 'Serum glucose concentration', 'timeFrame': 'Baseline'}, {'measure': 'Serum glucose concentration', 'timeFrame': '8 hours'}, {'measure': 'Serum glucose concentration', 'timeFrame': '16 hours'}, {'measure': 'Serum glucose concentration', 'timeFrame': '24 hours'}, {'measure': 'Serum glucose concentration', 'timeFrame': '72 hours'}, {'measure': 'Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha)', 'timeFrame': '24 hours'}, {'measure': 'NT-proBNP blood levels', 'timeFrame': '24 hours'}, {'measure': 'Death', 'timeFrame': '3 months'}, {'measure': 'Myocardial infarction (heart attack)', 'timeFrame': '3 months'}, {'measure': 'Measure of extent of heart failure (NYHA classification)', 'timeFrame': '72 hours'}, {'measure': 'Measure of extent of heart failure (NYHA classification)', 'timeFrame': '3 months'}, {'measure': 'Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization)', 'timeFrame': '6 months'}, {'measure': 'Death', 'timeFrame': '6 months'}, {'measure': 'Recurrent myocardial infarction (heart attack)', 'timeFrame': '6 months'}, {'measure': 'Stroke', 'timeFrame': '6 months'}, {'measure': 'Unplanned repeat revascularization', 'timeFrame': '6 months'}, {'measure': 'Development of heart failure', 'timeFrame': '6 months'}, {'measure': 'Cardiogenic shock', 'timeFrame': 'During index hospitalization (up to 6 months)'}, {'measure': 'Blood glucose < 3.0 mmol/L', 'timeFrame': 'During index hospitalization (up to 6 months)'}, {'measure': 'Hypotension (defined as SBP <90 mmHg)', 'timeFrame': 'During index hospitalization (up to 6 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'Percutaneous coronary intervention', 'Reperfusion injury', 'Exenatide', 'Magnetic resonance imaging'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of exenatide on myocardial injury in patients undergoing emergent percutaneous coronary intervention (PCI) for ST segment elevation myocardial infarction or heart attack (STEMI).', 'detailedDescription': 'This is a Phase II randomized, double-blind, placebo-controlled study of patients with STEMI. Those who agree to participate will be immediately randomized to one of two groups: a 24-h infusion of exenatide; or a 24 h infusion of placebo. We will assess the ability of exenatide to reduce ischemic injury. This study will serve as safety evaluation study as well as a pilot for a larger multicentre trial powered for clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.\n* Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Symptomatic hypoglycemia (serum glucose \\<3.3 µmol/L; 60 mg/dl)\n* Diabetes mellitus requiring insulin therapy\n* Diabetic ketoacidosis\n* Coronary anatomy warranting emergent coronary artery bypass graft surgery\n* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)\n* Need for hemodialysis\n* Malignancy, HIV, or central nervous system disorder\n* Cardiopulmonary resuscitation \\>15 min and compromised level of consciousness.\n* Cardiogenic shock\n* Current participation in any research study involving investigational drugs or devices\n* Inability to give informed consent\n* Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)\n* Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission\n* History of pancreatitis\n* Known end stage renal failure or known eGFR \\<30 mL/min\n* Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist'}, 'identificationModule': {'nctId': 'NCT01938235', 'acronym': 'EMPRES', 'briefTitle': 'Exenatide for Myocardial Protection During Reperfusion Study', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Exenatide for Myocardial Protection During Reperfusion Study: A Double-blind, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'MB001-001'}, 'secondaryIdInfos': [{'id': '9427-D0416-21C', 'type': 'OTHER', 'domain': 'Health Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exenatide', 'description': 'o Exenatide at a dose of 1.5 µg IV over 30 min followed by 1.2 µg/hr IV for 1.5 h (Rate1), followed by 1.9 µg/hr IV\\* for 22 h (Rate 2)\n\n\\*Once the creatinine clearance is available, if the value is \\<60 mL/min, the rate at 2 hours will be maintained at Rate 1 for the duration of the infusion. If the value becomes available after the 2-hour point, and the rate has already been changed to Rate 2, the infusion will be titrated back down to Rate 1 if the creatinine clearance is \\<60 mL/min.\n\nIf the creatinine clearance is \\<30 mL/min, the infusion will be discontinued and the patient will otherwise continue with all study procedures.\n\nA bolus administration of study medication is initiated preferably prior to reperfusion, or, if not possible, up to 30 minutes after the start of reperfusion to avoid delays in door-to-door balloon times.', 'interventionNames': ['Drug: Exenatide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours\\*.", 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'Intravenous bolus and 24-hour infusion of exenatide', 'armGroupLabels': ['Exenatide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous bolus and 24-hour infusion of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Linda Manasterski', 'role': 'CONTACT', 'email': 'linda.manasterski@albertahealthservices.ca', 'phone': '403-210-8548'}, {'name': 'Faisal Al Qoofi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Linda Kvill', 'role': 'CONTACT', 'email': 'linda.kvill@albertahealthservices.ca', 'phone': '780-735-5255'}, {'name': 'Neil Brass, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Suzanne Welsh', 'role': 'CONTACT', 'email': 'suzanne.welsh@albertahealthservices.ca', 'phone': '780-407-3572'}, {'name': 'Robert Welsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sonya Brons', 'role': 'CONTACT', 'email': 'bronsson@hhsc.ca', 'phone': '905-527-4322', 'phoneExt': '44602'}, {'name': 'Sanjit Jolly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hamilton Health Sciences - General Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mistre Alemayehu', 'role': 'CONTACT', 'email': 'mistre.alemayehu@lhsc.on.ca', 'phone': '519-685-8500', 'phoneExt': '35625'}, {'name': 'Shahar Lavi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L3Y 2P7', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kim Robbins', 'role': 'CONTACT', 'email': 'kim.yorkpci@gmail.com', 'phone': '905-235-5966'}, {'name': 'Warren Cantor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Suneet Khurana', 'role': 'CONTACT', 'email': 'suneet.khurana@sunnybrook.ca', 'phone': '416-480-4520'}, {'name': 'Mina Madan, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brigita Zile', 'role': 'CONTACT', 'email': 'zileb@smh.ca', 'phone': '416-864-6060', 'phoneExt': '4130'}, {'name': 'John J Graham, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nadia Asif', 'role': 'CONTACT', 'email': 'nadia.asif@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '4969'}, {'name': 'Vladimir Dzavik, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Toronto General Hospital, University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michele Jadin', 'role': 'CONTACT', 'email': 'michele.jadin@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3007'}, {'name': 'Olivier Bertrand, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval)', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Val Panzov, MD', 'role': 'CONTACT', 'email': 'panzovV@smh.ca', 'phone': '416-864-6060', 'phoneExt': '7125'}, {'name': 'Melissa Giamou, BSc', 'role': 'CONTACT', 'email': 'giamoum@smh.ca', 'phone': '416-864-6060', 'phoneExt': '7889'}], 'overallOfficials': [{'name': 'Vladimir Dzavik, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Health Network, Toronto'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Research and Innovation in Interventional Cardiology and Cardiac Intensive Care, Division of Cardiology', 'investigatorFullName': 'Vladimír Džavík', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}