A Randomized, Controlled Trial Evaluating the Benefits of Early Up-Front-loaded High Dose Tirofiban in the Treatment of Patients with ST-segment Elevation Myocardial Infarction, who are Candidates for Primary Angioplasty

Trial Profile

A Randomized, Controlled Trial Evaluating the Benefits of Early Up-Front-loaded High Dose Tirofiban in the Treatment of Patients with ST-segment Elevation Myocardial Infarction, who are Candidates for Primary Angioplasty

Completed
Phase of Trial: Phase II

Latest Information Update: 27 Jul 2017

At a glance

  • Drugs Tirofiban (Primary) ; Aspirin; Clopidogrel; Heparin
  • Indications Embolism and thrombosis; Myocardial infarction
  • Focus Pharmacodynamics; Registrational
  • Acronyms On-TIME-2
  • Most Recent Events

    • 05 Jul 2017 Results of post hoc subgroup analysis (n=918, patients with samples for NT-proBNP) published in the Heart
    • 07 Jul 2016 Results of pooled analysis from an open label phase and a double blind phase of the study, published in a Medicure media release.
    • 07 Jul 2016 According to Medicure media release, the company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) communicating that its initial review of the application is complete; however, it cannot approve the application in its present form and requested additional information.
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