This study examines acute ischemic stroke in patients who are taking direct oral anticoagulants, which are medications that help prevent blood clots. An acute ischemic stroke occurs when a blood vessel in the brain becomes blocked, preventing blood and oxygen from reaching brain tissue. The study will use tenecteplase, a medication that works by dissolving blood clots, or placebo. Tenecteplase is also known as Metalyse and will be given as a single dose through an injection into a vein. The purpose of the study is to find out whether treatment with tenecteplase improves recovery and functional ability after stroke in patients taking direct oral anticoagulants compared to placebo.
Patients in the study must have stroke symptoms that started within the past six hours, or in some cases with special imaging tests showing specific patterns in the brain, symptoms may have been present for a longer time or the exact time may be unknown. Before joining the study, patients will have brain imaging with either CT or MRI scans to make sure there is no bleeding in the brain. CT stands for computed tomography and MRI stands for magnetic resonance imaging, both of which are types of scans that create detailed pictures of the brain. Some patients may need additional specialized imaging tests that look at blood flow in the brain to check if they are suitable for the study.
During the study, patients will receive either tenecteplase or placebo as a single treatment. After treatment, doctors will monitor patients closely for any side effects, particularly any bleeding complications. The main assessment will occur ninety days after treatment, when doctors will evaluate how well patients have recovered and their ability to perform daily activities. Additional assessments will look at early improvement in stroke symptoms after twenty-four hours, quality of life, thinking abilities, and various safety measures including any bleeding events that may occur.
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