Rationale, design and population baseline characteristics of the PERFORM vascular project: an ancillary study 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) trial.
OBJECTIVE
PERFORM is exploring the efficacy of terutroban versus aspirin for secondary prevention in patients with a history of ischemic stroke or transient ischemic attacks (TIAs). The PERFORM Vascular Project will evaluate the effect of terutroban on progression of atherosclerosis, as assessed by change in carotid intima-media thickness (CIMT) in a subgroup of patients.


RESULTS
The Vascular Project includes structural (CIMT, carotid plaques) and functional (carotid stiffness) vascular studies in all patients showing at least one carotid plaque at entry. Expected mean follow-up is 36 months. Primary endpoint is rate of change of CIMT. Secondary endpoints include emergent plaques and assessment of carotid stiffness. 1,100 patients are required for 90% statistical power to detect treatment-related CIMT difference of 0.025 mm. The first patient was randomized in April 2006.


CONCLUSIONS
The PERFORM Vascular Project will investigate terutroban's effect on vascular structure and function in patients with a history of ischemic stroke or TIAs.
Hennerici
Michael G
MG
Department of Neurology, University of Heidelberg, Mannheim, Germany. hennerici@neuro.ma.uni-heidelberg.de
Bots
Michiel L
ML
Ford
Ian
I
Laurent
Stéphane
S
Touboul
Pierre Jean
PJ
D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000494:pharmacology / Q000627:therapeutic use; D050197:Atherosclerosis / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology; D002339:Carotid Arteries / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D016893:Carotid Stenosis / Q000188:drug therapy / Q000473:pathology / Q000503:physiopathology; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D023381:Endpoint Determination; D015340:Epidemiologic Research Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000494:pharmacology / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000494:pharmacology / Q000627:therapeutic use; D011422:Propionates / Q000494:pharmacology / Q000627:therapeutic use*; D011786:Quality Control; D015203:Reproducibility of Results; D018401:Sample Size; D020521:Stroke / Q000517:prevention & control*; D017539:Tunica Intima / Q000187:drug effects / Q000473:pathology; D018616:Ultrasonography, Doppler, Duplex
D009281:Naphthalenes; D010975:Platelet Aggregation Inhibitors; D011422:Propionates; C501362:terutroban; D001241:Aspirin