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

Primary Purpose

Myocardial Infarction

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
placebo
PRT060128 Potassium
Sponsored by
Portola Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring STEMI, ACS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tallahassee Memorial Medical Center
  • Iowa Heart Center
  • University of Kentucky Hospital, Gill Heart Center
  • Maine Medical Center
  • Washington Adventist Hospital
  • Henry Ford Hospital
  • Genesys Regional Medical Center
  • St. Joseph Mercy - Oakland
  • William Beaumont Hospital
  • William Beaumont Hospital - Troy Cardiology
  • Lindner Clinical Trial Center
  • Geisinger Medical Center
  • The Heart Center
  • Foothills Hospital
  • Royal Alexandria Hospital
  • University of Alberta Hospital
  • Vancouver General Hospital
  • St. Paul's Hospital
  • Victoria Heart Institute, Royal Jubilee Hospital
  • Atlantic Health Services
  • General Hospital - Heath Sciences Centre
  • Queen Elizabeth II Health Sciences Centre
  • Hamilton Health Sciences
  • London Health Sciences
  • Trillium Health Centre - Mississaugua
  • Soutlake Regional Health Centre
  • Sunnybrook Health Sciences Centre
  • Montreal Heart Institute
  • Centre Hospitalier Universitaire de Montreal - Hotel Dieu
  • Hospital du Sacre Coeur
  • Regina General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Placebo for each Dose cohort: 10, 20, 40, and 60 mg

Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 16, 2007
Last Updated
August 3, 2023
Sponsor
Portola Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00546260
Brief Title
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Administrative reasons.
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Portola Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
STEMI, ACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo for each Dose cohort: 10, 20, 40, and 60 mg
Arm Title
2
Arm Type
Experimental
Arm Description
Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
administration of iv bolus prior to angiography
Intervention Type
Drug
Intervention Name(s)
PRT060128 Potassium
Intervention Description
administration of iv bolus prior to angiography
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI
Description
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 Frame
Time for contrast to reach a standardized distal coronary landmark in the culprit vessel
Title
Percentage ST-segment Resolution Prior to PCI
Description
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.
Time Frame
Before primary PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew T. Roe, MD, MHS
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Gibson, MD, MS
Organizational Affiliation
PERFUSE Angiographic Core Laboratory and Data Coordinating Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tallahassee Memorial Medical Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Iowa Heart Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
University of Kentucky Hospital, Gill Heart Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
St. Joseph Mercy - Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital - Troy Cardiology
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Lindner Clinical Trial Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
The Heart Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Foothills Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Facility Name
Royal Alexandria Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H3V7
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
Victoria Heart Institute, Royal Jubilee Hospital
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R4R2
Country
Canada
Facility Name
Atlantic Health Services
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L4L2
Country
Canada
Facility Name
General Hospital - Heath Sciences Centre
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B3V6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H3A7
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Facility Name
London Health Sciences
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Facility Name
Trillium Health Centre - Mississaugua
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B2P7
Country
Canada
Facility Name
Soutlake Regional Health Centre
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y2R2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1C8
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Montreal - Hotel Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W1T8
Country
Canada
Facility Name
Hospital du Sacre Coeur
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N1C5
Country
Canada
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P0W5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19958867
Citation
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.
Results Reference
derived
Links:
URL
http://www.portola.com
Description
Sponsor home page

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

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