Faridkot

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are evaluating whether Tranexamic Acid can improve outcomes in adults who have a spontaneous intracerebral haemorrhage, a type of stroke caused by bleeding within the brain. This trial focuses on patients who arrive within 4.5 hours after stroke symptoms begin. The study is important because this condition has a high risk of death and disability, and early treatment with haemostatic drugs like Tranexamic Acid could potentially reduce bleeding and improve recovery. The trial is conducted across multiple centers in India and aims to enroll 3400 patients. Participants will be randomly assigned to one of two groups. One group receives 2 grams of Tranexamic Acid given intravenously over 45 minutes, along with intensive blood pressure control to maintain systolic pressure below 140 mmHg for seven days. The other group receives standard care with the same blood pressure management protocol. Both groups will have CT brain scans after 24 hours to check for changes in bleeding. Blood pressure is closely monitored every 15 minutes for the first hour and then hourly for six hours. During the study, patients will be assessed using neurological scores on day 7 and their quality of life and functional status will be measured on day 90. Researchers will monitor death rates within 30 days, changes in haematoma size, neurological impairments, and overall recovery. The study includes regular neurological evaluations and brain imaging as needed. Participation lasts at least 90 days to evaluate outcomes and safety.