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

This study has been terminated.
(Administrative reasons.)
Sponsor:
Information provided by:
Portola Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00546260
First received: October 16, 2007
Last updated: December 28, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Myocardial Infarction
Drug: placebo
Drug: PRT060128 Potassium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Portola Pharmaceuticals:

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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Time for contrast to reach a standardized distal coronary landmark in the culprit vessel ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before primary PCI ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00546260

  Show 31 Study Locations
Sponsors and Collaborators
Portola Pharmaceuticals
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
  More Information

Additional Information:
No publications provided by Portola Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Gretler, MD, Portola Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00546260     History of Changes
Other Study ID Numbers: 07-113
Study First Received: October 16, 2007
Results First Received: November 23, 2010
Last Updated: December 28, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Portola Pharmaceuticals:
STEMI
ACS

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014