Researchers at University of California, San Francisco will begin enrolling patients next week in a clinical trial testing whether the leg cramp medication cilostazol can prevent a second ischemic stroke, aiming to cut recurrence rates by 50% across more than two thousand participants nationwide.
UC San Francisco Launches Nationwide Stroke Prevention Trial
A second ischemic stroke doubles the risk of death and triples the risk of long-term disability for patients. To combat this threat, the University of California, San Francisco will begin enrolling patients in a national study evaluating cilostazol, a medication approved to treat leg cramping and numbing associated with peripheral artery disease.
Stroke ranks as the fourth leading cause of death in the United States. Approximately 87 percent of all strokes are ischemic, affecting roughly 1 in 6 to 1 in 7 Americans. The trial is funded by the National Institute of Neurological Disorders and Stroke and will enroll more than 2,000 patients across 100 study sites throughout the country. Participants must have been diagnosed within the last six months with either an ischemic stroke or a high-risk transient ischemic attack.
How Cilostazol Operates Inside Brain Arteries
Both ischemic strokes and high-risk transient ischemic attacks stem from a blood clot or narrowed artery that restricts oxygen-rich blood flow to the brain. Standard preventative therapy typically relies on aspirin or clopidogrel to prevent blood from clumping and forming clots. Cilostazol offers a distinct advantage by protecting the lining of brain arteries without increasing the risk of brain bleeds.
The biological stakes following an initial neurological event are severe.
Researchers Look to Duplicate Results From East Asia
U.S. investigators were prompted to launch the trial following research conducted in Japan, China, and other East Asian nations. A 2019 study in Japan evaluated standard therapy alone compared to standard therapy combined with cilostazol. Within four years, 11.4 percent of patients on standard therapy experienced a subsequent stroke, compared to just 4.7 percent of patients who received the added medication. The frequency of side effects, including serious bleeding, remained similar between both groups.
Despite these encouraging findings, researchers note critical methodological differences between the foreign studies and the upcoming U.S. evaluation. Anthony S.
Without this gold standard, there’s the potential to introduce bias.
Unlike the Japanese study, the upcoming StrokeNet evaluation is structured as a double-blinded placebo trial where neither doctors nor participants know who receives the active treatment. Sreekrishnan also pointed out demographic distinctions in the earlier data, noting that 2 in 3 participants were male and all were Japanese
. Consequently, investigators emphasize that it remains unproven whether the same level of effectiveness will translate to the racially diverse population of the United States.
NIH StrokeNet Coordinates Multicenter Trial Leadership
The trial operates under the umbrella of NIH StrokeNet, a national research network dedicated to stroke prevention, acute treatment, and recovery. Kim serves as the principal investigator for the network’s regional coordinating center, overseeing trial execution at UCSF and partner sites. National trial leadership is shared by Adam de Havenon, MD, and Kevin Sheth, MD, of Yale, alongside Maarten Lansberg, MD, PhD, of Stanford.
Participants enrolled in the multicenter trial will be monitored for up to five years. Trial administrators have directed interested patients and clinicians to the StrokeNet Clarity Trial site for enrollment criteria and additional information.
Additional clinical background is reflected in broader health reporting data, such as records compiled within the Healthcare Cost and Utilization Project (HCUP) statistical briefs by researchers including Irene Fraser, Ph.D., Director of the Center for Delivery, Organization, and Markets at the Agency for Healthcare Research and Quality, alongside analytical contributions from organizations like Truven Health Analytics, Social & Scientific Systems, Inc., and Emory University.