Randomized, double-blind, placebo-controlled, international trial of the oral IIb/IIIa antagonist @entity61790 in coronary and XXXX .

@entity1 @entity455 @entity64 @entity66 @entity548 @entity63 @entity731 @entity61790 @entity117 @entity453 @entity1011 @entity583 @entity204
BACKGROUND: This is the primary report of the large-scale evaluation of @entity61790 , an orally administered IIb/IIIa receptor antagonist, a unique trial with respect to the platelet antagonist, protocol design, and inclusion of @entity66 in a significant proportion of @entity1 . METHODS AND RESULTS: @entity1 with @entity455 were randomized to @entity61790 30 or 50 mg BID on the basis of age and predicted @entity1011 clearance or placebo in addition to @entity117 at a dose ranging from 75 to 325 mg/d at the discretion of the physician-investigator. Follow-up was for up to 2 years. The primary end point was the composite of all-cause mortality, @entity583 , @entity64 , recurrent @entity63 requiring hospitalization, and urgent revascularization. Of 9190 @entity1 enrolled from 23 countries and 690 hospitals, 41% had @entity66 at the time of entry, and 59% had @entity453 . @entity204 occurred in 2.3% of placebo-assigned @entity1 and 3.0% of @entity61790 -group @entity1 (hazard ratio 1.33, 95% CI 1.03 to 1.72, P=0.026), and the cause of excess @entity204 was vascular related. There was no significant difference in the primary end point (17.5% compared with 16.4%, respectively; hazard ratio 0.94, 95% CI 0.85 to 1.03, P=0.19). Serious @entity548 was more frequent in the @entity61790 group (8.0% compared with 2.8%; P<0.001). Serious @entity548 was more common among @entity1 who received higher doses of @entity117 (>162 mg/d), with or without @entity61790 . CONCLUSIONS: @entity61790 , an orally administered platelet glycoprotein IIb/IIIa blocker, induced a 33% increase in @entity204 rate, which was vascular in origin and not affected by the type of @entity731 involvement at entry to the trial. Although the dose of @entity117 was not randomly assigned, the finding of increased @entity548 with doses >162 mg/d is noteworthy.
