Rhode Island Hospital was a major participant in a just-published international study that found new hope for preserving brain cells after stroke.
After 50 years of research and the testing of over 1,000 drugs, the study found that treating acute ischemic stroke patients with an experimental neuroprotective drug, combined with a surgical procedure to remove the clot, improves outcomes.
The research, published Feb. 20 in The Lancet, was based on a clinical trial at 48 leading stroke centers around the world. Rhode Island Hospital enrolled the third highest number of patients in the trial. The trial was spearheaded at Rhode Island Hospital by Ryan A. McTaggart, MD, director of neurointerventional radiology at Rhode Island Hospital, and colleagues Mahesh V. Jayaraman, MD, and Richard Haas, MD. All three are on the faculty The Warren Alpert Medical School of Brown University.
“Rhode Island Hospital’s stroke center has again been a top enrolling site in a landmark clinical trial for large vessel occlusion (LVO) stroke,” said McTaggart. “Our stroke center is dedicated to making sure all stroke patients in Rhode Island have early access to the best stroke care available; in many ways our team is defining it.”
Worldwide, 15 million people suffer a stroke each year – that’s one every 90 seconds in the United States. The results can be devastating. Ischemic stroke, the most common, is caused by a clot in a blood vessel in the brain. The sudden loss of blood flow causes brain cells to die, which can permanently affect speech, vision, balance and movement.
The double-blinded, randomized trial of the neuroprotective drug nerinetide, developed by NoNO Inc, was led by a team at the Cumming School of Medicine’s (CSM) Hotchkiss Brain Institute at the University of Calgary and by Alberta Health Services. In one scenario, nerinetide was given to patients in addition to the clot-busting drug alteplase. In the second scenario, patients who were not suitable for alteplase received only nerinetide. Both groups of patients had concurrent endovascular treatment (EVT) to remove the clot.
“A significant clinical benefit was seen in the group that did not get the clot-busting medication alteplase (tPA). The treatment effect modification by alteplase was confirmed by blood tests - In the patients who received both drugs, the alteplase negated the benefits of the nerinetide.”. This is the first study to show neuroprotection in humans is possible,” McTaggart said.
He noted that a future trial is now being planned for LVO stroke patients ineligible for alteplase.
Images of patients’ brains from the study show the expected size of the damage from the stroke is sizably reduced when nerinetide is administered and EVT is performed among patients not concurrently receiving alteplase.
“Compared to placebo, almost 20 per cent more patients who received nerinetide along with endovascular treatment, but did not receive alteplase, recovered from a devastating stroke – a difference between paralysis and walking out of the hospital,” said Dr. Michael Hill, MD, a neurologist at Foothills Medical Centre (FMC) and professor in the departments of Clinical Neurosciences and Radiology at the CSM.
Hill says the study provides evidence of a biological pathway that protects brain cells from dying when they are deprived of blood flow. Nerinetide targets the final stage of the brain cell’s life by stopping the production of nitric oxide within the cell.
“We really believe this is a new scientific observation,” said Hill. “There is evidence nerinetide promotes brain cell survival, offering neuroprotection until we can extract the clot. It opens the door to a new way of treating stroke.”
The results in the current study, called the ESCAPE-NA1 Trial, build on the success of the ESCAPE trial, in which the Calgary Stroke Program proved that a clot retrieval procedure known as EVT can dramatically improve patient outcomes after an acute ischemic stroke. During the procedure, a catheter is inserted in the groin and guided through blood vessels into the brain. A tiny metal mesh device is used to grab the clot and pull it out. The current study investigates whether administering nerinetide in addition to clot retrieval improves the patient’s ability to recover.
Learn more about the world-class stroke care at Rhode Island Hospital at the upcoming Rhode Island Stroke Symposium May 9, 2020.