Michael G Hennerici1. 1. University of Heidelberg, UMM , Theodor Kutzer Ufer 1-3, Mannheim DE-68135, Germany. hennerici@neuro.ma.uni-heidelberg.de
Abstract
BACKGROUND: One of the leading causes of mortality worldwide is ischemic stroke, which is a major contributor to neurological disability and dementia. Terutroban is a specific thromboxane A2 receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which make it a promising tool for secondary prevention of ischemic stroke. METHODS AND RESULTS: The Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin with Terutroban in Patients with a History of Ischemic Stroke or Transient Ischemic Attack (PERFORM) Study is an international, multicenter, randomized, double-blind, parallel-group study in patients aged > or =55 years who have suffered ischemic strokes (<3 months) or transient ischemic attacks (<8 days), and who are stable at inclusion with no intracranial hemorrhage or nonischemic neurological diseases. Patients are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy end point is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is evaluated by assessing hemorrhagic events. The first patient was randomized in February 2006 and more than 19,000 patients will be included. CONCLUSIONS: The PERFORM Study will explore the benefits of terutroban in secondary prevention of ischemic stroke. The study results are expected in 2011. Copyright 2009 S. Karger AG, Basel.
RCT Entities:
BACKGROUND: One of the leading causes of mortality worldwide is ischemic stroke, which is a major contributor to neurological disability and dementia. Terutroban is a specific thromboxane A2 receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which make it a promising tool for secondary prevention of ischemic stroke. METHODS AND RESULTS: The Prevention of Cerebrovascular and Cardiovascular Events of Ischemic Origin with Terutroban in Patients with a History of Ischemic Stroke or Transient Ischemic Attack (PERFORM) Study is an international, multicenter, randomized, double-blind, parallel-group study in patients aged > or =55 years who have suffered ischemic strokes (<3 months) or transient ischemic attacks (<8 days), and who are stable at inclusion with no intracranial hemorrhage or nonischemic neurological diseases. Patients are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy end point is a composite of ischemic stroke (fatal or nonfatal), myocardial infarction (fatal or nonfatal), or other vascular death (excluding hemorrhagic death of any origin). Safety is evaluated by assessing hemorrhagic events. The first patient was randomized in February 2006 and more than 19,000 patients will be included. CONCLUSIONS: The PERFORM Study will explore the benefits of terutroban in secondary prevention of ischemic stroke. The study results are expected in 2011. Copyright 2009 S. Karger AG, Basel.