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

Study Identifier:
07-113
ClinicalTrials.gov Identifier:
NCT00546260
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Heart, Blood & Circulatory - Other
Study Drug
  • Drug: placebo
  • Drug: PRT060128 Potassium
Date
Nov 2007 - Jul 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
18 - 75 Years

Study Details

Medical Condition
  • Heart, Blood & Circulatory - Other
Study Drug
  • Drug: placebo
  • Drug: PRT060128 Potassium
Date
Nov 2007 - Jul 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years years
Requirements Information
Inclusion and Exclusion 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.

Protocol Summary

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

Trial Locations

Location
Status
Location
Tallahassee Memorial Medical Center
Tallahassee, Florida, United States, 32308
Status
N/A
Location
Iowa Heart Center
Des Moines, Iowa, United States, 50314
Status
N/A
Location
University of Kentucky Hospital, Gill Heart Center
Lexington, Kentucky, United States, 40536
Status
N/A
Location
Maine Medical Center
Portland, Maine, United States, 04102
Status
N/A
Location
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
Status
N/A
Location
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Status
N/A
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