Study Stopped
Administrative reasons.
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
ERASE-MI
Randomized Trial to Evaluate Effect of Adjunctive Antiplatelet Therapy With Intravenous PRT060128, a Selective P2Y12-Receptor Inhibitor, Before Primary Percutaneous Intervention (PCI) in ST-Elevation Myocardial Infarction (STEMI) Patients
1 other identifier
interventional
70
2 countries
31
Brief Summary
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
January 25, 2011
CompletedAugust 16, 2023
August 1, 2023
8 months
October 16, 2007
November 23, 2010
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI
Time for contrast to reach a standardized distal coronary landmark in the culprit vessel
Percentage ST-segment Resolution Prior to PCI
Before primary PCI
Study Arms (2)
1
PLACEBO COMPARATORPlacebo for each Dose cohort: 10, 20, 40, and 60 mg
2
EXPERIMENTALExperimental drug for each Dose cohort: 10, 20, 40, and 60 mg
Interventions
Eligibility Criteria
You may qualify if:
- Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥ 0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset within 6 hours of hospital presentation.
You may not qualify if:
- Cardiogenic shock (systolic blood pressure \< 90 mm Hg requiring vasopressor or hemodynamic support)
- Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) \> 180 mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or symptoms of a congenital or acquired bleeding disorder or vascular malformation.
- Recent gastrointestinal bleeding within the last 30 days.
- Known thrombocytopenia (platelet count \< 100,000/mm3).
- Any treatment with a fibrinolytic agent within the last 7 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Tallahassee Memorial Medical Center
Tallahassee, Florida, 32308, United States
Iowa Heart Center
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
Related Publications (1)
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.
PMID: 19958867DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Because Part II of the study was not completed and Part I had a small sample size, no conclusions could be drawn regarding efficacy.
Results Point of Contact
- Title
- Kevin Romanko, Senior Director Clinical Operations
- Organization
- Portola Pharmaceuticals Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew T. Roe, MD, MHS
Duke Clinical Research Institute
- PRINCIPAL INVESTIGATOR
Michael Gibson, MD, MS
PERFUSE Angiographic Core Laboratory and Data Coordinating Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 18, 2007
Study Start
November 1, 2007
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
August 16, 2023
Results First Posted
January 25, 2011
Record last verified: 2023-08