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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.
Actively Recruiting
Researchers are evaluating whether Tranexamic Acid can improve outcomes in adults who have experienced spontaneous intracerebral hemorrhage (a type of stroke caused by bleeding in the brain). This trial is a Phase 4, multicenter, randomized, open-label study conducted in India, targeting patients who arrive within 4.5 hours of stroke symptom onset. The study aims to address the high burden and mortality associated with this condition, especially due to hematoma expansion early after symptom onset. Previous trials showed reduced hematoma growth but no clear improvement in functional outcomes, so this larger study seeks to clarify Tranexamic Acid's effect when given early. Participants will be randomly assigned to one of two groups: the treatment group will receive an intravenous dose of 2 grams of Tranexamic Acid diluted in 100 ml of sodium chloride 0.9%, given over 45 minutes. The control group will receive standard care according to hospital protocols. Both groups will undergo intensive blood pressure management to keep systolic pressure below 140 mmHg within one hour, maintained for seven days, using antihypertensive medications chosen by the treating clinician. Repeat brain CT scans will be done 24 hours after treatment to monitor hematoma volume, and urgent imaging will be performed if neurological deterioration occurs. Throughout the study, patients will be closely monitored with neurological assessments on day 7 using NIH Stroke Scale and modified Rankin Scale scores. At 90 days, researchers will evaluate quality of life and functional outcomes. Blood pressure medication usage and doses will be recorded during the first week. The primary outcome measured is death within 30 days. The study plans to enroll 3400 patients across 50 stroke centers in India, with follow-up lasting at least 90 days after treatment.