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| ID | Type | Description | Link |
|---|---|---|---|
| 9427-D0416-21C | Other Identifier | Health Canada |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | 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) *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. If the creatinine clearance is <30 mL/min, the infusion will be discontinued and the patient will otherwise continue with all study procedures. A 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. |
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| Placebo | Placebo Comparator | o Placebo bolus over 30 min followed by placebo infusion at 'Rate 1' for 1.5 h, followed by 'Rate 2' for 22 hours*. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | Intravenous bolus and 24-hour infusion of exenatide |
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| Measure | Description | Time Frame |
|---|---|---|
| Ratio of final infarct size at 3 months over area at risk at 72 hours post randomization (using cMRI) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular global and regional LV systolic ejection fraction | 72 hours | |
| Left ventricular global and regional LV systolic ejection fraction | 3 months | |
| Left ventricular volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Val Panzov, MD | Contact | 416-864-6060 | 7125 | panzovV@smh.ca |
| Melissa Giamou, BSc | Contact | 416-864-6060 | 7889 | giamoum@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Dzavik, MD | University Health Network, Toronto | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Recruiting | Calgary | Alberta | T2N 4Z6 | Canada |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Placebo | Drug | Intravenous bolus and 24-hour infusion of placebo |
|
| 72 hours |
| Left ventricular volume | 3 months |
| Infarct size/area of risk (measured by cMRI) | 3 months |
| Myocardial enzyme levels (troponin I and CK-MB) | 24 hours |
| ST segment elevation resolution (measured by ECG) | 1 hour |
| ST segment elevation resolution (measured by ECG) | 24 hours |
| ST segment elevation resolution (measured by ECG) | 72 hours |
| ST segment elevation resolution (measured by ECG) | 3 months |
| Angiographic myocardial blush score | At the time of the PCI procedure |
| Serum glucose concentration | Baseline |
| Serum glucose concentration | 8 hours |
| Serum glucose concentration | 16 hours |
| Serum glucose concentration | 24 hours |
| Serum glucose concentration | 72 hours |
| Inflammatory marker levels (interleukin-6, interleukin-10, TNF-alpha) | 24 hours |
| NT-proBNP blood levels | 24 hours |
| Death | 3 months |
| Myocardial infarction (heart attack) | 3 months |
| Measure of extent of heart failure (NYHA classification) | 72 hours |
| Measure of extent of heart failure (NYHA classification) | 3 months |
| Major adverse cardiac events (defined as a combined outcome of death, recurrent myocardial infarction, stroke, and unplanned repeat revascularization) | 6 months |
| Death | 6 months |
| Recurrent myocardial infarction (heart attack) | 6 months |
| Stroke | 6 months |
| Unplanned repeat revascularization | 6 months |
| Development of heart failure | 6 months |
| Cardiogenic shock | During index hospitalization (up to 6 months) |
| Blood glucose < 3.0 mmol/L | During index hospitalization (up to 6 months) |
| Hypotension (defined as SBP <90 mmHg) | During index hospitalization (up to 6 months) |
| Royal Alexandra Hospital | Recruiting | Edmonton | Alberta | T5H 3V9 | Canada |
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| University of Alberta Hospital | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
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| Hamilton Health Sciences - General Site | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
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| London Health Sciences Centre | Recruiting | London | Ontario | N6A 5A5 | Canada |
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| Southlake Regional Health Centre | Recruiting | Newmarket | Ontario | L3Y 2P7 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| St. Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| Toronto General Hospital, University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
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| Institut universitaire de cardiologie et de pneumologie de Quebec (Hopital Laval) | Recruiting | Québec | Quebec | G1V 4G5 | Canada |
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |