Why the study?
Does combination reperfusion therapy with tenecteplase and eptifibatide improve TIMI grade 3 flow at 60 min compared to tenecteplase monotherapy in patients with acute myocardial infarction?
Does combination reperfusion therapy with tenecteplase and eptifibatide improve TIMI grade 3 flow at 60 min compared to tenecteplase monotherapy in patients with acute myocardial infarction?
The INTEGRITI trial is designed to evaluate the efficacy of combining tenecteplase and eptifibatide on 60-minute TIMI 3 flow in patients with acute myocardial infarction.
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Will determine if eptifibatide plus tenecteplase improves early TIMI 3 flow in AMI; extends randomized evidence on combination reperfusion.
Combination reperfusion therapy with partial-dose fibrinolytics and glycoprotein (GP) IIb/IIIa inhibitors for patients with acute myocardial infarction has been shown to accelerate and improve reperfusion compared with fibrinolytic monotherapy. Tenecteplase is a single-bolus fibrinolytic agent that has been shown to have equivalent efficacy to alteplase (the current ‘gold-standard’ fibrinolytic agent), and thus has the potential to simplify fibrinolytic dosing. Eptifibatide is a synthetic GP IIb/IIIa inhibitor that has been evaluated as an adjunct to fibrinolytic therapy. The combination of various doses of tenecteplase with eptifibatide will be evaluated in the dose-finding phase of the Integrilin and Tenecteplase for Acute Myocardial Infarction (INTEGRITI) trial to determine the optimal dose to use in the dose confirmation phase. Tenecteplase monotherapy will be compared with optimal-dose tenecteplase plus eptifibatide in the dose confirmation phase of the trial. The primary end point of both phases of the trial will be Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow in the infarct-related artery at 60 min. INTEGRITI will also evaluate other useful indicators of reperfusion efficacy, including the corrected TIMI frame count, the TIMI myocardial perfusion grade, ST segment resolution assessed with serial static electrocardiograms and continuous ST segment monitoring, and plasma/serum markers. Thus, the INTEGRITI trial will extensively evaluate the relative benefits of combination reperfusion therapy for the treatment of acute myocardial infarction, and will aid in the planning of a subsequent large-scale phase III trial.
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Roe et al. (2001) studied this question.
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