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Circulation. 1996;93:637

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(Circulation. 1996;93:637.)
© 1996 American Heart Association, Inc.

Articles

EPILOG and CAPTURE Trials Halted Because of Positive Interim Results

James J. Ferguson, III, MD

From the Texas Heart Institute, Houston.

Correspondence to James J. Ferguson III, MD, Clinical Cardiology Research, Texas Heart Institute, 6720 Bertner, PO Box 20345, MCI-191, Houston, TX 77030.

On December 14, 1995, Centocor Inc announced that it was stopping the EPILOG trial (Evaluation of PTCA to Improve Long-term Outcome by c7E3 GP IIb/IIIa Receptor Blockade) because of positive findings at the first interim analysis of 1500 patients. As originally designed, the trial was to have included 4800 patients, both low risk and high risk, undergoing percutaneous intervention, randomized to a control arm: "standard"-dose heparin (100 U/kg bolus, titrated to an activated clotting time of >=300 s) plus placebo, or to one of two experimental arms: standard-dose heparin plus the GP IIb/IIIa antibody c7E3 Fab (ReoPro 0.25 mg/kg bolus plus 0.125 µg · kg-1 · min-1 [up to a maximum of 10 µg/min] infusion for 12 hours), or "low"-dose heparin (70 U/kg bolus, to achieve an activated clotting time >=200 s) plus c7E3 Fab. An interim analysis on the first 1500 patients enrolled in the trial was conducted in December of 1995, focusing specifically on the primary-outcome end points of death and myocardial infarction. Because efficacy of the experimental arms exceeded predetermined stopping levels (P<.0001), the Safety and Efficacy Monitoring Committee (SEMC) recommended that the study be stopped. The SEMC also noted that major bleeding events with c7E3 Fab were essentially the same as with placebo. Full data from all patients enrolled in the trial before it was stopped will be presented after complete adjudication of all end points, sometime in 1996.

On December 20, Centocor also announced that CAPTURE . . . [Full Text of this Article]




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