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Final Results of the RHAPSODY Trial: A Multi‐Center, Phase 2 Trial Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A‐APC, A Recombinant Variant of Human Activated Protein C, in Combination with Tissue Plasminogen Activator, Mechanical Thrombectomy or both in Moderate to Severe Acute Ischemic Stroke

2018; Wiley; Volume: 85; Issue: 1 Linguagem: Inglês

10.1002/ana.25383

1531-8249

Patrick D. Lyden, Kent E. Pryor, Christopher S. Coffey, Merit Cudkowicz, Robin Conwit, Ashutosh P. Jadhav, Robert N. Sawyer, Jan Claassen, Opeolu Adeoye, Shlee Song, Peter Hannon, Natalia S. Rost, Archana Hinduja, Michel T. Torbey, Jin‐Moo Lee, Curtis Benesch, Michael Rippee, Marilyn M. Rymer, Michael T. Froehler, E. Clarke Haley, Mark D. Johnson, Jon Yankey, Kim Magee, Julie C. Qidwai, Howard Levy, E. Mark Haacke, Eliza C. Miller, Thomas P. Davis, Arthur W. Toga, John H. Griffin, Berislav V. Zloković,

Lipoproteins and Cardiovascular Health

Agonism of protease-activated receptor (PAR) 1 by activated protein C (APC) provides neuro- and vasculoprotection in experimental neuroinjury models. The pleiotropic PAR1 agonist, 3K3A-APC, reduces neurological injury and promotes vascular integrity; 3K3A-APC proved safe in human volunteers. We performed a randomized, controlled, blinded trial to determine the maximally tolerated dose (MTD) of 3K3A-APC in ischemic stroke patients.