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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014