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Vol. 27, No. 5, 2009
Issue release date: April 2009
Cerebrovasc Dis 2009;27:509–518

Rationale and Design of a Randomized, Double-Blind, Parallel-Group Study of Terutroban 30 mg/day versus Aspirin 100 mg/day in Stroke Patients: 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

Bousser M.G. · Amarenco P. · Chamorro A. · Fisher M. · Ford I. · Fox K. · Hennerici M.G. · Mattle H.P. · Rothwell P.M.
aHôpital Lariboisière (AP-HP), INSERM U-740 and bHôpital Bichat, INSERM U-698, Paris-Diderot University, Paris, France; cHospital Clinic de Barcelona, Barcelona, Spain; dUniversity of Massachusetts Memorial Health Care, Worcester, Mass., USA; eRobertson Centre for Biostatistics, Glasgow, fRoyal Brompton Hospital, London, and gJohn Radcliffe Hospital, Oxford, UK; hUniversity of Heidelberg, Mannheim, Germany; iInselspital, University of Bern, Bern, Switzerland

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Background: Ischemic stroke is the leading cause of mortality worldwide and a major contributor to neurological disability and dementia. Terutroban is a specific TP receptor antagonist with antithrombotic, antivasoconstrictive, and antiatherosclerotic properties, which may be of interest for the secondary prevention of ischemic stroke. This article describes the rationale and design of 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, which aims to demonstrate the superiority of the efficacy of terutroban versus aspirin in secondary prevention of cerebrovascular and cardiovascular events. Methods and Results: The PERFORM Study is a multicenter, randomized, double-blind, parallel-group study being carried out in 802 centers in 46 countries. The study population includes patients aged ≥55 years, having suffered an ischemic stroke (≤3 months) or a transient ischemic attack (≤8 days). Participants are randomly allocated to terutroban (30 mg/day) or aspirin (100 mg/day). The primary efficacy endpoint 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 being evaluated by assessing hemorrhagic events. Follow-up is expected to last for 2–4 years. Assuming a relative risk reduction of 13%, the expected number of primary events is 2,340. To obtain statistical power of 90%, this requires inclusion of at least 18,000 patients in this event-driven trial. The first patient was randomized in February 2006. Conclusions: The PERFORM Study will explore the benefits and safety of terutroban in secondary cardiovascular prevention after a cerebral ischemic event.

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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