Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI (ERASE-MI)

June 22, 2026 updated by: Alexion Pharmaceuticals, Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
Time Frame: Time for contrast to reach a standardized distal coronary landmark in the culprit vessel
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
Time Frame: Before primary 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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-113

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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