The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention.
The purpose of this medical research study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to only abciximab given during coronary intervention. This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death, and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment. Patients will receive either abciximab and reteplease or abciximab alone. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2,461
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h
The Composite of All-Cause Mortality or Complications of MI at 90 Days.
Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization).
Time frame: 90 days
Complications of MI as Defined in the Primary Outcome Measure Through 90 Days
The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring \> 48 hours after randomization.
Time frame: 90 Days
All-Cause Mortality Through 90 Days
All cause mortality occurred through 90 days from randomization.
Time frame: 90 days
Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization
Time frame: 60 to 90 minutes
All-Cause Mortality Through 1 Year
All-cause mortality through 1 year from randomization.
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Covina, California, United States
Unnamed facility
Modesto, California, United States
Unnamed facility
Newark, Delaware, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Tallahassee, Florida, United States
...and 217 more locations