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

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

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: placebo; Drug: PRT060128 Potassium

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Foothills Hospital
    • Edmonton, Alberta, Canada, T6G2B7
      • University of Alberta Hospital
    • Edmonton, Alberta, Canada, T5H3V7
      • Royal Alexandria Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z1M9
      • Vancouver General Hospital
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital
    • Victoria, British Columbia, Canada, V8R4R2
      • Victoria Heart Institute, Royal Jubilee Hospital
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L4L2
      • Atlantic Health Services
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B3V6
      • General Hospital - Heath Sciences Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H3A7
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L2X2
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences
    • Mississauga, Ontario, Canada, L5B2P7
      • Trillium Health Centre - Mississaugua
    • Newmarket, Ontario, Canada, L3Y2R2
      • Soutlake Regional Health Centre
    • Toronto, Ontario, Canada, M4N3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T1C8
      • Montreal Heart Institute
    • Montreal, Quebec, Canada, H2W1T8
      • Centre Hospitalier Universitaire de Montreal - Hotel Dieu
    • Montreal, Quebec, Canada, H4N1C5
      • Hospital du Sacre Coeur
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4P0W5
      • Regina General Hospital
• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Medical Center
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Heart Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Hospital, Gill Heart Center
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Pontiac, Michigan, United States, 48341
      • St. Joseph Mercy - Oakland
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital - Troy Cardiology
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Clinical Trial Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • The Heart Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo for each Dose cohort: 10, 20, 40, and 60 mg	Drug: placebo; administration of iv bolus prior to angiography
Experimental: 2; Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg	Drug: PRT060128 Potassium; administration of iv bolus prior to angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Sponsor home page

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 17, 2007
• First Posted (Estimated): October 18, 2007

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: STEMI; ACS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Myocardial Infarction
• Other Study ID Numbers: 07-113