Initially, this Phase II study investigated the effects of daily administration of DMP 754, a IIb/IIIa platelet inhibitor, versus aspirin on the inhibition of platelet aggregation, the incidenceof bleeding and thrombocytopenia in patients with coronary artery disease over a 6 month period of time. The study was amended in March 1998 to include combination therapy arms of DMP 754 and aspirin. Preliminary data suggested increased risk of bleeding so the protocol was amended in July 1998 to remove the 2.0 mg DMP 754 + Aspirin arm and its comparitor (2.0mg DMP 754 alone). We enrolled 8 patients between May and October 1998. Of those eight patients, two were discontinued, one due to decrease in platelet count and the other because of a positive hemoccult. DuPont closed enrollent December 1998 after meeting enrollment goals. The six-month study follow-up will conclude in May 1999. Clinical endpoints include death, progression to myocardial infarction, CABG, PTCA for recurrent ischemia, hospitalization for ischemia or unstable angina. We expect to generate an abstract for presentation, on which Mayo investigators will be co-authors, in late 1999 followed by a manuscript.
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