Clinical trial NCT00546260: Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Myocardial Infarction
Keywords: STEMI
ACS
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
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
timeFrame: 30 days
Secondary outcomes:
measure: Corrected TIMI Frame Count (cTFC) in the Infarct Artery on the Initial Diagnostic Angiogram Before Primary PCI
timeFrame: Time for contrast to reach a standardized distal coronary landmark in the culprit vessel
measure: Percentage ST-segment Resolution Prior to PCI
timeFrame: Before primary PCI
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Memorial Medical Center
state: Florida
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Hospital, Gill Heart Center
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Pontiac
country: United States
facility: St. Joseph Mercy - Oakland
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy Cardiology
state: Michigan
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Kingsport
country: United States
facility: The Heart Center
state: Tennessee
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandria Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute, Royal Jubilee Hospital
state: British Columbia
city: St. John
country: Canada
facility: Atlantic Health Services
state: New Brunswick
city: St. John's
country: Canada
facility: General Hospital - Heath Sciences Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Centre - Mississaugua
state: Ontario
city: Newmarket
country: Canada
facility: Soutlake Regional Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier Universitaire de Montreal - Hotel Dieu
state: Quebec
city: Montreal
country: Canada
facility: Hospital du Sacre Coeur
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
Study officials:
affiliation: Duke Clinical Research Institute
name: Matthew T. Roe, MD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: PERFUSE Angiographic Core Laboratory and Data Coordinating Center
name: Michael Gibson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.ahj.2009.10.010.