Khaberni - An international study revealed promising results for a new experimental drug that may change the methods of stroke prevention for patients who are most at risk of recurrence, without increasing the risk of bleeding.
The study showed that the drug "Asundexian," an experimental anticoagulant, helped reduce the risk of a new stroke in people who had recently suffered a stroke or transient ischemic attack (TIA) due to extracardiac clot, compared to conventional treatment or placebo.
The study included 12,327 patients from 37 countries, who were enrolled in the study within just 72 hours of injury, whether from non-cardiac origin stroke (which represents the majority of ischemic strokes (stroke associated with clots)) or a severe transient ischemic attack. Participants were regularly monitored over several months to detect any recurrent events.
Current treatment in such cases largely depends on antiplatelet drugs such as aspirin, which provide limited protection but may increase the risk of bleeding when used over long periods or with other drugs.
Researchers randomly divided the participants into two groups: a group that received "Asundexian" at a dose of 50 mg daily, and another that received a placebo, in addition to standard treatment.
The results showed the following:
A reduction in the risk of recurrent ischemic stroke to 6.2% for the drug group, compared to 8.4% in the placebo group (a reduction of 26%).
A reduction in major cardiac and vascular events to 9.2% compared to 11.1% (a reduction of 17%).
A reduction in strokes causing disability or death to 2.1% compared to 3% (a reduction of 31%).
No increase in bleeding events compared to conventional treatment.
Lead researcher Mike Sharma stated that the results represent "what researchers have been striving for decades," confirming that the benefit appeared consistently across different age and disease groups without increased bleeding complications.
For his part, co-researcher Ashkan Shoamanesh explained that "reducing the risk of stroke always came at the expense of increased bleeding, but these results change the equation," indicating that they offer hope for safer prevention.
The drug "Asundexian" works differently from traditional anticoagulants, as it targets active Factor XI (Factor XIa), an element involved in the formation of harmful clots, but does not play a significant role in stopping bleeding. This approach aims to prevent dangerous clots while preserving the body's natural clotting mechanisms.
This is the first successful Phase III trial to demonstrate the efficacy of an active Factor XI inhibitor in secondary stroke prevention, after previous attempts that did not achieve sufficient results or were associated with bleeding complications.
Despite these positive results, the drug "Asundexian" is still under regulatory review and has not yet been approved for clinical use.
The results of the clinical trial were published in the New England Journal of Medicine.
