Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI

Myocardial Infarction Clinical Trial

— ERASE-MI  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00546260
• Other study ID #: 07-113
• Status: Terminated
• Phase: Phase 2
• Start date: November 2007
• Est. completion date: July 2008

Study information

• Verified date: August 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Description:

Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• placebo
administration of iv bolus prior to angiography
• PRT060128 Potassium
administration of iv bolus prior to angiography

Locations

Country	Name	City	State
Canada	Foothills Hospital	Calgary	Alberta
Canada	Royal Alexandria Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
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	Centre Hospitalier Universitaire de Montreal - Hotel Dieu	Montreal	Quebec
Canada	Hospital du Sacre Coeur	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Soutlake Regional Health Centre	Newmarket	Ontario
Canada	Regina General Hospital	Regina	Saskatchewan
Canada	Atlantic Health Services	St. John	New Brunswick
Canada	General Hospital - Heath Sciences Centre	St. John's	Newfoundland and Labrador
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute, Royal Jubilee Hospital	Victoria	British Columbia
United States	Lindner Clinical Trial Center	Cincinnati	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Iowa Heart Center	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	The Heart Center	Kingsport	Tennessee
United States	University of Kentucky Hospital, Gill Heart Center	Lexington	Kentucky
United States	St. Joseph Mercy - Oakland	Pontiac	Michigan
United States	Maine Medical Center	Portland	Maine
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington Adventist Hospital	Takoma Park	Maryland
United States	Tallahassee Memorial Medical Center	Tallahassee	Florida
United States	William Beaumont Hospital - Troy Cardiology	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Portola Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	Before primary PCI

External Links

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