Phase 3 trial shows a reduction in recurrent ischemic stroke

OCEANIC-STROKE was a randomised, placebo-controlled, phase 3 trial that enrolled patients with a recent non-cardioembolic ischaemic stroke or high-risk TIA treated with background antiplatelet therapy (n=12,327). The patients received standard treatment with antiplatelet agents within 72 hours. Half were additionally treated with daily asundexian, while the other half received a placebo. Patients were followed for an average of 18 months.

Hope for protection

In the placebo group, 8.4% of patients experienced another stroke, compared with 6.2% in the asundexian group. This represents a 26% relative reduction in the risk of recurrent stroke. The combined risk of cardiovascular death, heart attack, or stroke was also lower among patients receiving asundexian. “The results of the OCEANIC-STROKE study suggest that this drug could be an important addition to current treatment to prevent new strokes,” says Jonathan Coutinho, a neurologist at Amsterdam UMC and program leader of the Neurovascular Disorders research program at Amsterdam Neuroscience. Countinho was one of the project leaders in the Netherlands. “These findings offer hope for improved protection against recurrent stroke for a large group of patients,” he added.

No increase in severe bleeding

A major concern with blood thinners is the risk of serious bleeding complications, including intracerebral hemorrhage. Asundexian was specifically designed to reduce clot formation while minimizing bleeding risk. The OCEANIC-STROKE study results support that approach. Serious bleeding occurred in 1.9% of patients receiving asundexian, compared with 1.7% in the placebo group. Rates of intracranial hemorrhage and fatal bleeding were also similar between the two groups. “The fact that the risk of recurrent stroke decreases without a clear increase in major bleeding makes this drug particularly interesting,” says Coutinho. “Achieving that balance is often one of the greatest challenges in stroke care.”

The fact that the risk of recurrent stroke decreases without a clear increase in major bleeding makes this drug particularly interesting. Achieving that balance is often one of the greatest challenges in stroke care.”

Jonathan Coutinho

Neurologist & Program Leader Neurovascular Disorders

International collaboration

The study was initiated by fellow neurologists from Canada in collaboration with Bayer and conducted in 37 countries at more than 700 hospitals, from Canada to Kazakhstan. A total of 12,327 patients participated, including approximately 100 in the Netherlands. Most participants had experienced an ischemic stroke, while a smaller proportion had suffered a high-risk TIA. Since the study is a Phase 3 clinical study, the drug is in the research phase and not yet available to patients outside of the study setting.

Potential role in future stroke care

The findings suggest that this next-generation anticoagulant could become an important addition to existing antiplatelet therapy for preventing recurrent stroke. If confirmed in future studies, the treatment could eventually help establish a new standard of care for patients who have experienced a stroke or TIA.

“Another large global study evaluating a drug similar to asundexian is currently underway,” Coutinho said. “The results are expected next year. Those findings will help determine whether this class of blood thinners can become a valuable addition to stroke treatment.”

Image: Adobe Stock