Phase
Condition
Congestive Heart Failure
Heart Defect
Myocardial Ischemia
Treatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Onset of symptoms of AMI within six hours prior to randomisation
A twelve-lead electrocardiogram with one of the following: ST-segment elevation ≥ 0.1millivolt (mV) in two or more limb leads, or ≥ 0.2 mV in two or more contiguousprecordial leads indicative of AMI, or left bundle-branch block
Age ≥ 18
Informed consent received
Exclusion
Exclusion Criteria:
Hypertension defined as blood pressure > 180/110 mm Hg (systolic BP >180 mm Hg and/ordiastolic BP >110 mm Hg) on repeated measurements during current admission prior torandomization
Use of abciximab (ReoPro ®) or other glycoprotein-IIb/IIIa antagonists within thepreceding 7 days
Major surgery, biopsy of a parenchymal organ, or significant trauma within 2 months
Any minor head trauma and any other trauma occurring after onset of the currentmyocardial infarction
Any known history of stroke or transient ischemic attack or dementia
Any known structural damage of the central nervous system
Prolonged cardiopulmonary resuscitation (>10 minutes) in the previous two weeks
Current oral anticoagulation
Standard unfractionated heparin (heparin sodium) >5000 IU or a subcutaneous dosewithin 6 hours of randomization of a therapeutic dose of any low molecular weightheparin
Known thrombocytopenia (prior platelet count below 100000 cells/μl (100 x10**9/l))
Known renal insufficiency (prior S-creatinine >2.5 mg% (>220 μmol/l) for men and >2.0mg% (>175 μmol/l)) for women
Pregnancy or lactation, parturition within the previous 30 days. Women of childbearingpotential must have a negative pregnancy test, or use a medically accepted method ofbirth control
Treatment with an investigational drug under another study protocol in the past 7 days
Previous enrollment in this study
Known sensitivity to TNK-tPA, tPA, abciximab, heparin or low molecular weight heparin
Any other condition that the investigator feels would place the patient at increasedrisk if the investigational therapy is initiated
Inability to follow protocol and comply with follow-up requirements