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.

Abstract

PURPOSE:

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.

METHODS AND 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.

• Authors: Michael G Hennerici, Michiel L Bots, Ian Ford, Stéphane Laurent, Pierre Jean Touboul
• Journal: Cardiovascular drugs and therapy (Cardiovasc Drugs Ther) Vol. 24 Issue 2 Pg. 175-80 (Apr 2010) ISSN: 1573-7241 [Electronic] United States
• PMID: 20490906 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Naphthalenes
• Platelet Aggregation Inhibitors
• Propionates
• terutroban
• Aspirin

Topics

• Aged
• Aged, 80 and over
• Aspirin (pharmacology, therapeutic use)
• Atherosclerosis (drug therapy, pathology, physiopathology)
• Carotid Arteries (drug effects, pathology, physiopathology)
• Carotid Stenosis (drug therapy, pathology, physiopathology)
• Data Interpretation, Statistical
• Double-Blind Method
• Endpoint Determination
• Epidemiologic Research Design
• Female
• Humans
• Male
• Middle Aged
• Naphthalenes (pharmacology, therapeutic use)
• Platelet Aggregation Inhibitors (pharmacology, therapeutic use)
• Propionates (pharmacology, therapeutic use)
• Quality Control
• Reproducibility of Results
• Sample Size
• Stroke (prevention & control)
• Tunica Intima (drug effects, pathology)
• Ultrasonography, Doppler, Duplex