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Home » THE MEDICINES COMPANY COMPLETES ANGIOMAX PHASE III SAFETY TRIALS IN CARDIAC SURGERY
THE MEDICINES COMPANY COMPLETES ANGIOMAX PHASE III SAFETY TRIALS IN CARDIAC SURGERY
The Medicines Company has announced successful completion of the EVOLUTION-On Phase III clinical trial of Angiomax, the second of two safety trials of the Angiomax Phase III cardiac surgery program.
EVOLUTION-On evaluated the use of Angiomax (bivalirudin) as an anticoagulant during cardiac surgeries conducted with the use of a cardiac pulmonary bypass machine ("on-pump").
The primary objective of EVOLUTION-On was to demonstrate that Angiomax is a safe alternative anticoagulant to heparin with protamine reversal in on-pump cardiac surgery. The primary endpoint results, a comparison of rates of acute procedural success, met the prespecified objectives. Patients treated with Angiomax demonstrated a 95 percent success rate, compared to a 91.8 percent success rate in patients treated with heparin and protamine reversal. Acute procedural success was defined at seven days postsurgery as absence of death, Q-wave MI (heart attack), repeat operation or catheterization for coronary revascularization, or stroke.
KEYWORDS Drug Pipeline Alert
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