Actively Recruiting
Safety and Effectiveness of Intravenous Thrombolysis in Adults With Ischemic Stroke and Recent Use of Direct Oral Anticoagulants
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-08-16
2800
Participants Needed
33
Research Sites
39 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and functional outcomes of intravenous thrombolysis IVT in adult patients who have recently taken direct oral anticoagulants DOACs and experienced an acute ischemic stroke. This international, prospective observational registry aims to understand whether IVT can be safely administered to these patients and if it improves recovery. The study involves collecting data from about 2800 participants across multiple stroke centers and comparing three groups based on recent DOAC intake and IVT treatment status. Participants are divided into three groups those who have taken DOACs recently and receive IVT, those who have taken DOACs recently but do not receive IVT, and patients without recent DOAC intake who receive IVT. The study collects detailed information about the timing, dose, and type of IVT drugs used Tenecteplase and Alteplase, as well as any complications that occur. The follow-up period lasts 90 days after the stroke event. During the study, researchers will monitor participants for symptomatic intracerebral hemorrhage within 36 hours after IVT and assess functional outcomes at 90 days using the modified Rankin Scale. Secondary evaluations include stroke severity, stroke volume, mortality, major bleeding, and other adverse events within specified timeframes. Data collection involves clinical assessments and imaging to understand stroke progression and treatment effects. Participants are observed for an average of two years for related study outcomes.
CONDITIONS
Brief Title
Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Research Team
T
Thomas Meinel, MD, PhD
F
Freschta Zipser-Mohammadzada, PhD
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