Clinical Trial Helps Reduce Recurrent Strokes in Patients

Toni Blevins was shopping when she started to feel and speak oddly. It lasted only a moment, but the next day, it happened again. This time, her daughter, a nurse practitioner, was with her. She immediately recognized it as a medical emergency. After being admitted to ProMedica Toledo Hospital, she learned she had experienced two transient ischemic attacks, or a mini-strokes.

During treatment, Toni was faced with an important decision: Should she participate in a clinical trial? The clinical trial, called OCEANIC Stroke, was to evaluate the safety and efficacy of an investigational drug in preventing recurrent strokes.

“This investigational medication, called asundexian, was being evaluated to see if blocking a different step of the blood-clotting process would help prevent blood clots from forming without significant increase in major bleeding,” explains Melanie Pakulski, BSN, RN, lead neuroscience clinical research coordinator. “If the drug was successful, it would help reduce the number of recurrent strokes.

Positive Results Lead to FDA Approval

According to the Centers for Disease Control and Prevention, one in four strokes are in people who have had a previous stroke. Recurrent strokes are more likely to happen soon after a stroke, within 24 hours or a week. That’s why participants in this clinical trial had to enroll quickly after their stroke.

“My mom had lung cancer in 2008 and she did a clinical study, which was helpful for the researchers,” says Toni. “I decided to do it so someone could learn from it. I thought, if it’s helping somebody and I don’t have any concerns, then I should do it.”

Toni enrolled in the clinical study right away and continued to participate until the study ended in December 2025. She experienced no issues or side effects and experienced no further stroke or TIA events.

In February 2026, Bayer announced that the results of the study demonstrated a substantial 26% reduction in stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. In the study, the patients who received asundexian were less likely to suffer a secondary stroke compared to placebo.

The positive results of the study led to a Fast Track Designation by the U.S. Food and Drug Administration as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke.

Until having a stroke herself, Toni didn’t realize what a major health event a stroke was. Thankfully, she’s had a good recovery and has had no strokes since. Many stroke survivors have lasting side effects. In fact, stroke reduces mobility in more than half of stroke survivors age 65 and older. Unfortunately, stroke is also the leading cause of death for Americans.

Toni encourages stroke patients to learn more about clinical studies and ask questions about the potential side effects and benefits. For studies like OCEANIC Stroke, it can be the final step in gaining FDA approval to open the medication up to market.

More State-of-the-Art Stroke Treatments

The OCEANIC Stroke study is one of many available at ProMedica to advance stroke care and treatment. At ProMedica, current areas of research include the use of new catheter devices to remove clots and treat aneurysms (an abnormal bulge in an artery). Medications are also being studied to see if they effectively slow or stop the bleeding in a hemorrhagic stroke (caused by a ruptured blood vessel in the brain).

For ischemic strokes like Toni’s, new and improved clot-busting medications and medications to prevent future strokes are being tested. ProMedica has also recently participated in a study for treatment of chronic or subacute subdural hematomas, which led to FDA approval, as well as published work in New England Journal of Medicine.

“Our goal at ProMedica is to offer state-of-the-art treatment for every stroke patient and to go above and beyond by delivering advanced care that they wouldn’t otherwise have access to in this region,” says Melanie.

The selection for clinical studies is rigorous. She adds, “Our ProMedica stroke interventionalists are very respected in the field which allows us to participate in the most exceptional and cutting‑edge studies. They choose studies that they think will benefit our patients and answer important questions that will lead to better clinical outcomes.”

Clinical trials give patients an opportunity to access promising treatments that are not yet available to the public. For instance, the OCEANIC Stroke study began in July 2023, nearly three years before the FDA’s fast track designation.

Being part of a clinical study may mean the patient has additional lab testing, examinations and questionnaires. However, patient perception around clinical studies is generally positive.

“It’s heartwarming to hear the reasons why individuals want to participate,” shares Melanie. “They truly care about improving care for others and answering questions around treatments and care.”

Learn more about research and clinical trials throughout various specialties at ProMedica.

Melanie Pakulski, RN, is the lead neuroscience clinical research coordinator with ProMedica.