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Figure 2 ANTHEMTIMI-32 Design
The study had 2 phases: (A) a double-blind, randomized, placebo-controlled, ascending dose-ranging phase and (B) a single-arm, unblinded heparin de-escalation phase. In the dose-ranging phase (A), 203 patients with non-ST-segment elevation acute coronary syndrome (nSTE-ACS) managed with an early catheterization were randomized 4:1 to recombinant nematode anticoagulant protein c2 (rNAPc2) or matching placebo administered intravenously (IV) every 48 h for 1 to 3 doses in 8 panels of
25 patients each. In the heparin de-escalation phase (B), 26 patients received 10 µg/kg rNAPc2 and half-dose unfractionated heparin (UFH), followed by a second panel of 26 patients treated with 10 µg/kg rNAPc2 and no heparin. *Encouraged per current practice guidelines.
10 µg/kg dose panel repeated. ASA = aspirin; ECG = electrocardiogram; Enox = enoxaparin; GP = glycoprotein.