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.
- Publication date
- Publisher
Abstract
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 > or =55 years, having
suffered an ischemic stroke (< or =3 months) or a transient ischemic attack (< or
=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