On-TIME 2 Objective: To investigate whether the results of primary PCI can be improved by early administration of high bolus dose tirofiban at first medical contact (ambulance or referral center). Study: Phase 1 open label randomized(tirofiban/ no tirofiban), Phase 2 randomized, placebo controlled trial. Population: STEMI patients, symptoms < 24 hours. Endpoint: MACE at 30 days (Death, re-MI, urgent TVR).
Phase 1 N=414 Tirofiban High bolus+ infusion+ASA+ heparin+clopidogrel N=709 Transport to PCI center PCI Phase 2 N=984 Placebo/notirofiban (Bolus+infusion)+ASA+ heparin+clopidogrel n=689 On-TIME 2
On-TIME 2 Eventrate at 30 days (%) p=0.043 p=0.051 p=0.66 p=0.01 p=0.58
On-TIME 2 Deathrate at 1 year (%) p=0.078 p=0.061 p=0.77
On-TIME 2 Conclusion: Early, pre-hospital initiation of high-bolus tirofibanimproved clinical outcome after primary PCI in patients with STEMI. Ten Berg et al. J Am CollCardiol 2010;55:2446-55