The Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) was the pivotal clinical trial that established the efficacy and safety profile of AGGRASTAT in combination with heparin for the treatment of patients with acute coronary syndromes.¹  PRISM-PLUS was a multicenter, parallel, double-blind study that randomized 1915 patients with acute coronary syndromes and unstable angina or non–Q-wave/non–ST-elevation myocardial infarction (MI) in the previous 12 hours to AGGRASTAT (0.6 µg/kg/min for 30 minutes and 0.15 µg/kg/min infusion; n=345), AGGRASTAT (0.4 µg/kg/min for 30 minutes and 0.1 µg/kg/min infusion) with heparin (n=773), or heparin alone (n= 797) for 48 hours.  All patients received acetylsalicylic acid at randomization and daily thereafter unless contraindicated.  The nonheparin arm was discontinued early, and its data were not included in the analysis.  Invasive assessment was deferred for the first 48 hours.  Patients undergoing early percutaneous coronary intervention continued the study drug for 12 to 24 hours afterward.  The primary endpoint was a composite of death, MI, or refractory ischemia within seven days after randomization.*

• Incidence of primary endpoint was 12.9% with AGGRASTAT/heparin and 17.9% with heparin alone (32% risk reduction, p=0.004).
• After 30 days, relative risk of the combined endpoint was 22% (18.5% vs. 22.3%; p=0.03).
• At six months, risk of the combined endpoint was reduced by 19% (27.7% vs. 32.1%; p=0.02).
• Risk of death or MI was reduced by 43% (p=0.006) at day 7 and by 30% (p=0.03) at day 30 with AGGRASTAT/heparin vs. heparin alone.

*Rehospitalization for unstable angina was also counted in the composite primary endpoint when assessed at 7 days, 30 days, and 6 months.

See PRISM-PLUS page for additional information.