Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
NCT ID: NCT00546260
Last Updated: 2023-08-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
70 participants
INTERVENTIONAL
2007-11-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Placebo for each Dose cohort: 10, 20, 40, and 60 mg
placebo
administration of iv bolus prior to angiography
2
Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg
PRT060128 Potassium
administration of iv bolus prior to angiography
Interventions
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placebo
administration of iv bolus prior to angiography
PRT060128 Potassium
administration of iv bolus prior to angiography
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Portola Pharmaceuticals
INDUSTRY
Responsible Party
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Portola Pharmaceuticals, Inc.
Principal Investigators
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Matthew T. Roe, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Michael Gibson, MD, MS
Role: PRINCIPAL_INVESTIGATOR
PERFUSE Angiographic Core Laboratory and Data Coordinating Center
Locations
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Tallahassee Memorial Medical Center
Tallahassee, Florida, United States
Iowa Heart Center
Des Moines, Iowa, United States
University of Kentucky Hospital, Gill Heart Center
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
St. Joseph Mercy - Oakland
Pontiac, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
William Beaumont Hospital - Troy Cardiology
Troy, Michigan, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
The Heart Center
Kingsport, Tennessee, United States
Foothills Hospital
Calgary, Alberta, Canada
Royal Alexandria Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute, Royal Jubilee Hospital
Victoria, British Columbia, Canada
Atlantic Health Services
Saint John, New Brunswick, Canada
General Hospital - Heath Sciences Centre
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Trillium Health Centre - Mississaugua
Mississauga, Ontario, Canada
Soutlake Regional Health Centre
Newmarket, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Montreal - Hotel Dieu
Montreal, Quebec, Canada
Hospital du Sacre Coeur
Montreal, Quebec, Canada
Regina General Hospital
Regina, Saskatchewan, Canada
Countries
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References
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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.
Related Links
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Sponsor home page
Other Identifiers
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07-113
Identifier Type: -
Identifier Source: org_study_id
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