Ciraparantag safely and completely reverses the anticoagulant effects of low molecular weight heparin

摘要: Abstract Major bleeding with low molecular weight heparin (LMWH) therapy occurs in up to 5% of patients and its anticoagulation is only partially reversed by protamine sulfate. We studied the ability ciraparantag (PER977), a novel agent that reverses LMWH preclinical studies, reverse healthy volunteers. Methods In this phase 1/2 trial, 4 cohorts 10 volunteers received escalating doses (100 300 mg) or placebo (8:2 ratio) approximately 4 h after single subcutaneous dose enoxaparin, 1.5 mg/kg. Safety, pharmacokinetic pharmacodynamic effects were assessed. Results Complete reversal enoxaparin anticoagulation, measured reduction whole blood clotting time, was observed all subjects who ranging from 100 mg 300 mg. The occurred rapidly bolus injection persisted for duration study. At 12 h 24 h, differences time treated group compared no longer significant, consistent decline concentrations effects. No procoagulant signals detected as D-dimer, F1.2, tissue factor pathway inhibitor levels. Ciraparantag well tolerated transient, minor side Conclusion induced related manner produces signal deleterious adverse events