Positive Results For ReoPro In CAPTURE Trial

Centocor has halted the 1,400-patient CAPTURE trial of its glycoprotein IIb/IIIa antibody, ReoPro (abciximab; 7E3), in refractory unstable angina patients scheduled for coronary angioplasty due to positive findings at an interim analysis of 1,050 patients. The results of the interim analysis were reviewed by an independent monitoring committee, which concluded that the trial should be stopped early because efficacy in the primary endpoint (death, myocardial infarction or the need for urgent intervention within 30 days of treatment) exceeded the predetermined stopping rule.

The CAPTURE (Chimeric 7E3 Anti-Platelet Therapy in Unstable Angina Refractory to standard treatment) trial was a Phase III, randomized, double-blind, placebo-controlled study evaluating ReoPro in patients scheduled for urgent percutaneous transluminal coronary angioplasty due to refractory unstable angina. Patients were allocated to treatment with ReoPro or standard therapy (heparin, aspirin, or nitroglycerine) during the 24-hour period preceding PTCA and until one hour afterwards. CAPTURE was begun in third-quarter 1993.

ReoPro was significantly more effective than placebo in preventing the composite endpoint; although precise values were not available, the statistical significance exceeded the p-value set out by the monitoring committee requiring cessation of the trial (p<0.0072). Looking at bleeding rates, it was found that in both the treatment and placebo groups included in CAPTURE, rates of major bleeding were markedly lower than in the company's pivotal EPIC trial which formed the basis for the drug's approval in December 1994, at 1.7% for placebo and 2.9% in the ReoPro treated arm. This difference was not statistically different, according to Centocor.