Safety and Tolerability of a Modified TIMI-14 Protocol in AMI Patients: A Pilot Study

Journal of Clinical and Basic Cardiology 2002; 5 (2): 193-196

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Keywords: akuter Myokardinfarkt,  Glykoprotein-IIb-IIIa-Antagonist,  TIMI-14-Studie,  acute myocardial infarction,  GPIIb-IIIa-inhibitors,  TIMI-14 trial

Aim of the study was to evaluate the safety and tolerability of a modified combination of thrombolysis plus glycoprotein IIb/IIIa receptor inhibitors in AMI patients versus a TIMI-14 protocol. 132 hospitalised patients within 4 h from onset of symptoms were randomised (double blind) in two groups. Group Immediately (66 patients) received thrombolytic treatment (50 mg rtPA) according to TIMI-14 study and standard treatment with glycoprotein IIb/IIIa receptor inhibitors. Group After (66 patients) received thrombolytic treatment (50 mg rtPA in 30 min) and after 30 min from starting thrombolysis received glycoprotein IIb/IIIa receptor inhibitors. Group Immediately: 51 patients showed rapid reperfusion as confirmed by coronarography performed after 12-72 h. Group After: 60 patients showed rapid reperfusion as confirmed by coronarography after 12-72 h. Side effects were similar in both groups. Patients receiving a modified protocol showed a favourable trend in incidence of reperfusion. Our data suggest the possibility to use a modified protocol and show the feasibility, safety and tolerability of this different protocol in timing of combination of GP IIb/IIIa receptor inhibitors with thrombolysis in patients with AMI. The bleeding risk was similar in both groups. These very preliminary data suggest other and larger studies.