International Stroke Conference
Alexis N. Simpkins, MD, PhD
Session: Closing Main Event.
Date: Friday, January 26, 2018
Speaker: Patrick D. Lyden, MD, FAAN, FAHA, FANA, Carmen and Louis Warschaw Chair in Neurology, Cedars-Sinai Medical Center
At the closing remarks session, Dr. Patrick D. Lyden presented the first clinical trial use of a neuroprotectant post the new era of the embolectomy trials. The NeuroNEXT NN104 (RHAPSODY) Study was a phase II multi-center, double-blinded clinical trial in which a 3K3A-activated protein C (APC) was tested for safety. A secondary outcome measure included assessment of hemorrhagic transformation. The 3K3A-APC is both neuroprotective and vascular protective with preclinical evidence that suggests that it improves neurologic outcome and reduces risk of hemorrhagic transformation. In this study, patients received intravenous tPA and/or endovascular therapy, followed by 3K3A-APC within 2 hours of the acute intervention divided into 5 doses. Of the 110 patients enrolled, 45% of the patients received thrombolysis and endovascular therapy, and 54% were given tPA alone. There were 5 doses that were tested in the clinical trial using the continuous reassessment method, and the maximum dose was well tolerated. Hemorrhagic transformation was assessed on MRI 30 days post treatment.
Dr. Lyden concluded the presentation by stating that the study showed that 3K3A-APC is safe and tolerable, and although the difference in hemorrhagic transformation was not significantly lower in the patients that received 3K3A-APC, the trend was consistent with prior preclinical data. I was able to talk briefly with Dr. Lyden after his presentation to ask him about the planned future steps for 3K3A-APC. He stated that the plan will be to move forward to the next stage of clinical trials to look for efficacy in improving outcome, particularly in patients receiving endovascular therapy.