November 1, 2007EuroIntervention
Ongoing tirofiban in myocardial infarction evaluation (On-TIME) 2 trial: rationale and study design
Why the study?
Does pre-hospital initiation of high-dose bolus tirofiban improve residual ST-segment deviation in patients with STEMI undergoing primary PCI?
Population
958 (planned) patients with STEMI who undergo primary PCI, European clinical trial
Comparison
Pre-hospital initiation of high-dose bolus of… vs Placebo on background therapy of aspirin…
Design
Other, 1:1, double-blind, placebo-controlled
Follow-up
30 days
Authors
Discussion
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Implication
Pre-hospital high-dose tirofiban remains unproven for STEMI; this RCT leaves open its effect on post-PCI ST resolution and 30-day ischemic events.
Key Points
- To describe the rationale and design of the On-TIME 2 trial evaluating whether pre-hospital initiation of high-dose bolus tirofiban improves outcomes in patients with STEMI undergoing primary PCI.
- Randomized, double-blind, placebo-controlled, multicenter European clinical trial designed to enroll 958 patients with STEMI undergoing primary PCI.
- Participants are randomized 1:1 to receive pre-hospital pretreatment with tirofiban (25 µg/kg bolus and 0.15 µg/kg/min maintenance infusion) or placebo alongside background therapy of aspirin, unfractionated heparin, and high-dose clopidogrel.
- The primary endpoint is defined as the extent of residual ST-segment deviation (>3 mm deviation) measured 1 hour after PCI.
- The key secondary endpoint comprises the combined 30-day incidence of death, recurrent myocardial infarction, urgent target vessel revascularization, or thrombotic bailout.
Structured PICO
Does pre-hospital initiation of high-dose bolus tirofiban improve residual ST-segment deviation in patients with STEMI undergoing primary PCI?
P
Population
958 (planned) patients with STEMI who undergo primary PCI, European clinical trial
I
Intervention
Pre-hospital initiation of high-dose bolus of tirofiban (25 microg/kg bolus and 0.15 microg/kg/min maintenance infusion) on background therapy of aspirin, unfractionated heparin and high dose clopidogrel
C
Comparator
Placebo on background therapy of aspirin, unfractionated heparin and high dose clopidogrel
O
Outcome
Extent of residual ST-segment deviation (defined as percentage of patients with >3 mm deviation of ST segment) 1 hour after PCIsurrogate
The On-TIME 2 trial is designed to evaluate the efficacy of pre-hospital high-dose tirofiban in STEMI patients undergoing primary PCI.
Cite This Study
Hof et al. (2007) studied this question.