Do you really think your incompetent? stroke medical 'professionals' will get this into a protocol in your hospital? WOW, you're delusional!
Your so called competent? 'professionals' knew about Asundexian years ago and have been planning for its' use since then, right!
Do you prefer your doctor, hospital and board of director's incompetence NOT KNOWING? OR NOT DOING? Your choice; let them be incompetent or demand action!
Next-Generation Factor XIa Cuts Recurrent Stroke Risk by 26%
"The difference between treatment arms began early and continued throughout the treatment period," he said. Moreover, he added, the benefit with asundexian was observed across subgroups by age, sex, geographic region, risk factors for stroke, the delivery of hyperacute treatment, stroke severity, and plans for single or dual antiplatelet therapy.
Safety results were also impressive, with major bleeding per International Society on Thrombosis and Haemostasis criteria occurring in 1.9% of asundexian patients versus 1.7% of placebo patients (HR 1.10, 95% CI 0.85-1.44).
"I am especially struck by the divergence of the event curves over the entire years-long study period," said Richard Bernstein, MD, PhD, of Northwestern University in Chicago, who was not involved with the study. "This is a long-term treatment that doesn't increase hemorrhagic risk by very much. I plan to start using this medication as soon as I can."
Secondary endpoints from the over 12,300-patient trial included a numerical reduction in ischemic stroke in the first 90 days with asundexian compared with placebo (3.0% vs 3.5%, HR 0.84, 95% CI 0.69-1.02) and a significant reduction in disabling/fatal strokes (2.1% vs 3.0%, HR 0.69, 95% CI 0.55-0.87). Symptomatic intracranial hemorrhage was similar between groups (0.7% vs 0.6%, HR 1.15, 95% CI 0.74-1.80), as was any definition of bleeding. Asundexian, an oral, direct, small-molecule inhibitor of FXIa, thus fulfills the promise of uncoupling hemostasis from thrombosis, with a lower risk of complications compared with available anticoagulants."This is a big win for our highest-risk stroke patients with a history of atherosclerotic or non-lacunae stroke," Bernstein said. "There is a dramatic reduction in all the ischemic endpoints patients care about, without any significant increase in major or clinically relevant non-major bleeding." "Clinicians will need guidance on managing common clinical situations, like perioperative management, reversal in the setting of bleeding emergencies, and thrombolysis, in patients taking this medication," he told MedPage Today. "That doesn't mean we need clinical trial-level answers to these scenarios. We need best practices and practical advice based on the best evidence we have available as we get used to using this valuable new tool." The phase III OCEANIC-STROKE trial was conducted across 702 sites on several continents. After an initial screening within 72 hours of stroke, 12,327 patients were randomized to asundexian 50 mg once daily or placebo. Mean age was 68 years, and about one in three participants were women; 21-22% had a previous history of stroke or TIA, and 27% were current smokers. Among all participants, 95% had an ischemic stroke and 5% had a high-risk TIA. This index event was most commonly related to large-artery atherosclerosis (43%), stroke of undetermined etiology (30%), or small-vessel occlusion (23%). The median NIH Stroke Scale score was 2 at randomization. Acute treatment of the index stroke included IV thrombolysis or endovascular therapy in 27.4% of cases. Dual antiplatelet therapy was planned for nearly 63% of patients. Of note, another FXIa inhibitor, milvexian, had failed to reduce recurrent strokes in the phase II AXIOMATIC-SSP trial. Nonetheless, milvexian remains a candidate for secondary prevention in the ongoing phase III Librexia STROKE study, scheduled for completion this calendar year.
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