THE DRUG DOCKETApproved 9 November, asundexian is cleared alongside antiplatelet therapy to lower ischaemic stroke risk after a non-cardioembolic stroke or high-risk TIA. In a 12,327-patient trial it cut that risk by 26%.
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THE DRUG DOCKETThe FDA logged a Class I recall of nearly 21,000 vials of the blood-thinner argatroban on 28 October, citing particles - from cellulose to stainless steel - found in the solution of an intravenous anticoagulant.
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THE DRUG DOCKETThe FDA logged a Class I recall of Instrumentation Laboratory's HemosIL AcuStar HIT assay on 21 October. Certain lots can read up to 47% low, risking a missed diagnosis of heparin-induced thrombocytopenia.
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WHAT THE STUDY ACTUALLY SAYSA detailed safety analysis of the 12,254-patient OCEANIC-STROKE trial found no significant rise in major bleeding with the factor XI blocker, though lower gastrointestinal bleeding was more frequent.
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WHAT THE STUDY ACTUALLY SAYSIn 3,000 patients eligible for blood thinners, the device maker's trial found left atrial appendage closure noninferior to anticoagulant drugs, and superior for non-procedure-related bleeding at three years.
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WHAT THE STUDY ACTUALLY SAYSThe TRACK trial was stopped early for futility. The blood thinner failed to reduce a composite of cardiovascular events, while major bleeding rose by half. Bayer, which makes the drug, was a listed collaborator.
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EXPLAINERFor most adults who bruise more than they used to, the cause is thinner skin from ageing, sun or steroids, plus the aspirin and anticoagulants many older people take. A few patterns point elsewhere.
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WHAT THE STUDY ACTUALLY SAYSSelf-testing and self-managing warfarin cut clot events by roughly 40%, and self-management also lowered deaths — one of the few at-home tests with randomised evidence of real benefit.
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WHAT THE STUDY ACTUALLY SAYSLIBREXIA-ACS enrolled 14,194 patients before stopping for futility. Milvexian did not reduce events, but intracranial and fatal bleeding were identical to placebo, which is the class's whole premise.
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WHAT THE STUDY ACTUALLY SAYSGuidelines have hedged on anticoagulation for people with one stroke risk factor. SINGLE-AF randomised 1,803 patients in South Korea, and the events it counted were very few in both arms.
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WHAT THE STUDY ACTUALLY SAYSThe STABLED trial randomized 331 atrial fibrillation patients with a recent stroke to ablation plus anticoagulation or anticoagulation alone. The two groups ended up nearly identical.
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