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.
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
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
Adrogué, Argentina
Buenos Aires, Argentina
Corrientes, Argentina
Merlo, Argentina
Rosario, Argentina
San Martín, Argentina