A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.
A Muticenter, Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy and Safety of Reteplease and Abciximab Combination Therapy With Abciximab Alone Administered Early or Just Prior to Primary Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction.
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.
Inclusion Criteria:
Exclusion Criteria:
Benesov U Prahy, Czechia
Havíøov 1, Czechia
Karniva-Ray N/A, Czechia
Praha 10 N/A, Czechia
Tøebíè 1, Czechia
Tøinec 1, Czechia
Hjÿrring N/A, Denmark
Kÿbenhavn Nv N/A, Denmark
Kÿbenhavn Sud N/A, Denmark
Kÿbenhavn Ÿ, Denmark
Ÿlborg, Denmark
Ÿrhus N, Denmark
Nancy Cedex N/A, France
Gdynia Poland, Poland
Nowy Dwor M, Poland
Warszawa Poland, Poland
Arcadia Pretoria N/A, South Africa
Cape Town Western Province, South Africa
Roodepoort Central Gauteng, South Africa