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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
History of Changes

October 16, 2007
December 28, 2010
November 2007
July 2008   (final data collection date for primary outcome measure)
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.
Efficacy, Safety and Tolerability [ Time Frame: 30 days ]
Complete list of historical versions of study NCT00546260 on ClinicalTrials.gov Archive Site
  • 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.
Evaluation of Corrected TIMI frame count or pre-PCI ST-segment resolution [ Time Frame: 1 day ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
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)

Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Myocardial Infarction
  • Drug: placebo
    administration of iv bolus prior to angiography
  • Drug: PRT060128 Potassium
    administration of iv bolus prior to angiography
  • Placebo Comparator: 1
    Placebo for each Dose cohort: 10, 20, 40, and 60 mg
    Intervention: Drug: placebo
  • Experimental: 2
    Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg
    Intervention: Drug: PRT060128 Potassium
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
July 2008
July 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00546260
07-113
Yes
Daniel Gretler, MD, Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals
Not Provided
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
Portola Pharmaceuticals
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP