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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
Author(s) -
Lyden Patrick,
Pryor Kent E.,
Coffey Christopher S.,
Cudkowicz Merit,
Conwit Robin,
Jadhav Ashutosh,
Sawyer Robert N.,
Claassen Jan,
Adeoye Opeolu,
Song Shlee,
Han Peter,
Rost Natalia S.,
Hinduja Archana,
Torbey Michel,
Lee JinMoo,
Benesch Curtis,
Rippee Michael,
Rymer Marilyn,
Froehler Michael T.,
Clarke Haley E.,
Johnson Mark,
Yankey Jon,
Magee Kim,
Qidwai Julie,
Levy Howard,
Mark Haacke E.,
Fawaz Miller,
Davis Thomas P.,
Toga Arthur W.,
Griffin John H.,
Zlokovic Berislav V.
Publication year - 2019
Publication title -
annals of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.764
H-Index - 296
eISSN - 1531-8249
pISSN - 0364-5134
DOI - 10.1002/ana.25383
Subject(s) - medicine , placebo , tolerability , thrombolysis , intracerebral hemorrhage , stroke (engine) , population , randomized controlled trial , clinical trial , adverse effect , anesthesia , surgery , gastroenterology , pathology , mechanical engineering , alternative medicine , environmental health , myocardial infarction , subarachnoid hemorrhage , engineering
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.