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Administrative reasons.
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Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo for each Dose cohort: 10, 20, 40, and 60 mg |
|
| 2 | Experimental | Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | administration of iv bolus prior to angiography |
| |
| PRT060128 Potassium |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days | TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit. TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10-15%. GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention. GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention. Stroke:New focal neurologic deficit that does not resolve within 24 hours. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI | This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter. | Time for contrast to reach a standardized distal coronary landmark in the culprit vessel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew T. Roe, MD, MHS | Duke Clinical Research Institute | Principal Investigator |
| Michael Gibson, MD, MS | PERFUSE Angiographic Core Laboratory and Data Coordinating Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Memorial Medical Center | Tallahassee | Florida | 32308 | United States | ||
| Iowa Heart Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19958867 | Derived | Berger JS, Roe MT, Gibson CM, Kilaru R, Green CL, Melton L, Blankenship JD, Metzger DC, Granger CB, Gretler DD, Grines CL, Huber K, Zeymer U, Buszman P, Harrington RA, Armstrong PW. Safety and feasibility of adjunctive antiplatelet therapy with intravenous elinogrel, a direct-acting and reversible P2Y12 ADP-receptor antagonist, before primary percutaneous intervention in patients with ST-elevation myocardial infarction: the Early Rapid ReversAl of platelet thromboSis with intravenous Elinogrel before PCI to optimize reperfusion in acute Myocardial Infarction (ERASE MI) pilot trial. Am Heart J. 2009 Dec;158(6):998-1004.e1. doi: 10.1016/j.ahj.2009.10.010. |
| Label | URL |
|---|---|
| Sponsor home page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Comparator |
| FG001 | Experimental | Experimental Cohorts (10, 20, 40, 60 mg) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
administration of iv bolus prior to angiography |
|
| Percentage ST-segment Resolution Prior to PCI | The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI. | Before primary PCI |
| Des Moines |
| Iowa |
| 50314 |
| United States |
| University of Kentucky Hospital, Gill Heart Center | Lexington | Kentucky | 40536 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| St. Joseph Mercy - Oakland | Pontiac | Michigan | 48341 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital - Troy Cardiology | Troy | Michigan | 48085 | United States |
| Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| The Heart Center | Kingsport | Tennessee | 37660 | United States |
| Foothills Hospital | Calgary | Alberta | T2N2T9 | Canada |
| Royal Alexandria Hospital | Edmonton | Alberta | T5H3V7 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G2B7 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z1M9 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z1Y6 | Canada |
| Victoria Heart Institute, Royal Jubilee Hospital | Victoria | British Columbia | V8R4R2 | Canada |
| Atlantic Health Services | Saint John | New Brunswick | E2L4L2 | Canada |
| General Hospital - Heath Sciences Centre | St. John's | Newfoundland and Labrador | A1B3V6 | Canada |
| Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H3A7 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L2X2 | Canada |
| London Health Sciences | London | Ontario | N6A5A5 | Canada |
| Trillium Health Centre - Mississaugua | Mississauga | Ontario | L5B2P7 | Canada |
| Soutlake Regional Health Centre | Newmarket | Ontario | L3Y2R2 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N3M5 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T1C8 | Canada |
| Centre Hospitalier Universitaire de Montreal - Hotel Dieu | Montreal | Quebec | H2W1T8 | Canada |
| Hospital du Sacre Coeur | Montreal | Quebec | H4N1C5 | Canada |
| Regina General Hospital | Regina | Saskatchewan | S4P0W5 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Comparator |
| BG001 | Experimental | Experimental Cohorts (10, 20, 40, 60 mg) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Thrombolysis in Myocardial Infarction (TIMI) Major/Minor Bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/Moderate Bleeding Through Hospital Discharge, and Intracranial Hemorrhage Through 30 Days | TIMI Major:Intracranial bleeding or a decrease in the hemoglobin concentration of 5g/dL or more, or 15% or greater decrease in hematocrit. TIMI Minor:Hemoglobin concentration decreased by 3g/dL (but <5g/dL) or the hematocrit decreased by 10-15%. GUSTO Severe/life threatening:Intracranial hemorrhage or bleeding that causes hemodynamic compromise requiring intervention. GUSTO Moderate:Bleeding that requires bloodtransfusion but does not lead to hemodynamic compromise requiring intervention. Stroke:New focal neurologic deficit that does not resolve within 24 hours. | All subjects receiving some component of study drug (the "as-treated" population) | Posted | Number | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI | This measure was used to assess flow in the epicardial artery. It is the number of cine frames required for contrast to reach a standardized distal coronary landmark in the culprit vessel and was to be counted using an electronic frame counter. | Per protocol | Posted | Median | Inter-Quartile Range | frames per minute | Time for contrast to reach a standardized distal coronary landmark in the culprit vessel |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage ST-segment Resolution Prior to PCI | The relative effect of PRT060128 on ST-segment measured after PCI and expressed as a percent of ST-Segment prior to PCI. This measure was used to evaluate the dethrombotic and early reperfusion effects of PRT060128 in STEMI. | Per protocol. | Posted | Median | Inter-Quartile Range | Percentage of ST-segment Resolution | Before primary PCI |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Comparator | 8 | 36 | 15 | 36 | ||
| EG001 | Experimental | Experimental Cohorts (10, 20, 40, 60 mg) | 2 | 34 | 21 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Chest pain | General disorders and administration site conditions | MedDRA (10.1) | Systematic Assessment |
| |
| Vessel puncture site haemorrhage | General disorders and administration site conditions | MedDRA (10.1) | Systematic Assessment |
| |
| Thrombosis in device | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Pyrexia | General disorders and administration site conditions | MedDRA (10.1) | Systematic Assessment |
| |
| Vessel puncture site haematoma | General disorders and administration site conditions | MedDRA (10.1) | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders and administration site conditions | MedDRA (10.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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Because Part II of the study was not completed and Part I had a small sample size, no conclusions could be drawn regarding efficacy.
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo. Additionally, individual publication may occur after coordinated multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Romanko, Senior Director Clinical Operations | Portola Pharmaceuticals Inc. | 650-246-7305 | kromanko@portola.com |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| Between 18 and 65 years |
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| >=65 years |
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| Dose 40 mg |
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| Dose 60 mg |
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