LAn international study has revealed promising results for a new experimental drug that could change the way strokes are prevented in patients most at risk of recurrence, without increasing the risk of bleeding.
The study showed that the experimental anticoagulant drug Asondexian helped reduce the risk of a new stroke in people who had recently suffered a stroke or a transient ischemic attack (TIA) caused by an extracardiac clot, compared to conventional treatment or a placebo.
The study included 12,327 patients from 37 countries, enrolled within just 72 hours of experiencing either a non-cardiac stroke (which represents the majority of ischemic strokes) or a severe transient ischemic attack (TIA). Participants were followed up regularly over several months to monitor for any recurring events.
Current treatment in such cases often relies on antiplatelet drugs such as aspirin, which provide limited protection but may increase the risk of bleeding when used for long periods or with other drugs.
The researchers randomly divided the participants into two groups: one group received Asondexian at a dose of 50 mg daily, and the other received a placebo, in addition to standard treatment.
The risk of recurrent ischemic stroke decreased to 6.2% in the drug group, compared to 8.4% in the placebo group (a 26% decrease).
Major cardiovascular events decreased to 9.2% compared to 11.1% (a decrease of 17%).
Strokes causing disability or death decreased to 2.1% compared to 3% (a decrease of 31%).
No increase in bleeding cases was recorded compared to traditional treatment.
Lead researcher Mike Sharma said the results represent "what researchers have been seeking for decades," stressing that the benefit appeared consistently across different age groups and medical conditions without increasing bleeding complications.
For his part, co-researcher Ashkan Shumanesh explained that "reducing the risk of stroke has always come at the expense of increased bleeding, but these results change the equation," noting that they offer hope for safer prevention.
Asondexane works differently from traditional anticoagulants. It targets active factor XIa, a component involved in the formation of harmful blood clots but which plays little role in stopping bleeding. This approach aims to prevent dangerous clots while preserving the body's natural clotting mechanisms.
This is the first phase 3 trial to successfully demonstrate the efficacy of an active factor XI inhibitor in secondary stroke prevention, following previous attempts that did not achieve sufficient results or were associated with hemorrhagic complications.
Despite these positive results, the drug "Asondexian" is still under regulatory review and has not yet received approval for clinical use.
The results of the clinical trial were published in the New England Journal of Medicine.
