Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
- Registration Number
- NCT00546260
- Lead Sponsor
- Portola Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo Placebo for each Dose cohort: 10, 20, 40, and 60 mg 2 PRT060128 Potassium Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI Time for contrast to reach a standardized distal coronary landmark in the culprit vessel 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 Before primary 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.
Trial Locations
- Locations (31)
Maine Medical Center
🇺🇸Portland, Maine, United States
Tallahassee Memorial Medical Center
🇺🇸Tallahassee, Florida, United States
William Beaumont Hospital - Troy Cardiology
🇺🇸Troy, Michigan, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Trillium Health Centre - Mississaugua
🇨🇦Mississauga, Ontario, Canada
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Victoria Heart Institute, Royal Jubilee Hospital
🇨🇦Victoria, British Columbia, Canada
Atlantic Health Services
🇨🇦St. John, New Brunswick, Canada
London Health Sciences
🇨🇦London, Ontario, Canada
Hospital du Sacre Coeur
🇨🇦Montreal, Quebec, Canada
St. Joseph Mercy - Oakland
🇺🇸Pontiac, Michigan, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier Universitaire de Montreal - Hotel Dieu
🇨🇦Montreal, Quebec, Canada
Regina General Hospital
🇨🇦Regina, Saskatchewan, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Soutlake Regional Health Centre
🇨🇦Newmarket, Ontario, Canada
Lindner Clinical Trial Center
🇺🇸Cincinnati, Ohio, United States
General Hospital - Heath Sciences Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
The Heart Center
🇺🇸Kingsport, Tennessee, United States
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
University of Kentucky Hospital, Gill Heart Center
🇺🇸Lexington, Kentucky, United States
Royal Alexandria Hospital
🇨🇦Edmonton, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada