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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the use of tenecteplase compared to standard medical care for adults who have had an acute ischemic stroke caused by blockages in medium-sized brain arteries. This Phase 3 trial focuses on patients whose stroke symptoms began between 4.5 and 24 hours prior to treatment and who meet specific imaging and clinical criteria. The study aims to better understand the safety and effectiveness of tenecteplase in this particular group, as previous trials have shown limited benefit from thrombectomy for such cases. Participants will be randomly assigned to receive either tenecteplase at a dose of 0.25 mg per kilogram of body weight (up to 25 mg) as a single intravenous bolus or standard medical treatment, which may include aspirin and/or clopidogrel. Eligibility is determined using brain imaging techniques such as CT angiography or MRI to confirm the location and extent of the vessel blockage and to assess tissue at risk. The treatment is administered within 4.5 to 24 hours after the patient was last seen well, including wake-up and unwitnessed strokes. During the 90-day study period, researchers will assess participants' recovery using the modified Rankin Scale (mRS), focusing on the proportion achieving a score of 1 or less, indicating minimal or no disability. Participants will undergo neurological assessments, imaging studies, and clinical evaluations. Safety and adherence to the treatment protocol will be closely monitored. The trial also includes follow-up to observe long-term outcomes and any adverse effects related to the treatments.
Actively Recruiting
Researchers are evaluating the use of albumin combined with endovascular treatment in patients who have acute ischemic stroke affecting the anterior circulation. This phase 3, multicenter, open-label clinical trial aims to verify the safety and effectiveness of adding albumin to reperfusion therapy for these patients. The study enrolls adults aged 18 to 80 years who have had a large vessel occlusion stroke and meet specific clinical criteria. Participants are randomly assigned to one of two groups: one group receives albumin together with endovascular therapy, and the other group receives endovascular therapy alone. Albumin is administered intravenously at a dose of 0.5 g/kg (up to 37.5 g) on the first day and then daily on days two, three, and four. All patients receive standard acute stroke treatment and secondary prevention according to current American stroke guidelines. Initial evaluations include brain imaging (CT or MRA) to locate the blockage and check for bleeding, as well as laboratory tests and stroke severity scoring. Throughout the study, vital signs and neurological assessments are recorded. After 90 days from randomization, patients are followed up by telephone to assess recovery using quality of life scales and functional outcomes. The main measure of success is the proportion of patients achieving a good functional status or returning to their baseline level at 90 days. Safety and efficacy are carefully monitored during this period to understand the impact of albumin therapy in this patient population.