Ongoing tirofiban in myocardial infarction evaluation (On-TIME) 2 trial: rationale and study design.

Aims: Delays in initiation of treatment because of transportation of high-risk patients with ST-elevation myocardial infarction (STEMI) are associated with worse clinical outcome. Glycoprotein IIb/IIIa receptor inhibitors improve initial patency of the infarct-related vessel and reduce thrombotic complications in patients undergoing percutaneous coronary intervention (PCI).

Methods And Results: The Ongoing Tirofiban In Myocardial infarction Evaluation (On-TIME) 2 trial is a randomised, double-blind, European clinical trial to evaluate the benefits of pre-hospital initiation of high-dose bolus of tirofiban, a glycoprotein IIb/IIIa receptor inhibitor, on background therapy of aspirin, unfractionated heparin and high dose clopidogrel, for patients with STEMI who undergo primary PCI. Eligible patients will be randomised 1:1 to pretreatment with a 25 microg/kg bolus and 0.15 microg/kg/min maintenance infusion of tirofiban or placebo. The primary endpoint is the extent of residual ST-segment deviation (defined as percentage of patients with >3 mm deviation of ST segment) 1 hour after PCI. The key secondary endpoint is the combined occurrence of death, recurrent myocardial infarction, urgent target vessel revascularisation, or thrombotic bailout at 30 days. The trial will continue until 958 patients are randomly assigned to treatment.

Conclusions: The On-TIME 2 trial evaluates whether pre-hospital initiation of high-dose bolus tirofiban is effective for patients with STEMI who are candidates to undergo PCI. This placebo-controlled trial will provide important evidence regarding the benefit of initiating a GP IIb/IIIa inhibitor, in combination with high-dose clopidogrel and unfractionated heparin.