Anand

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.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.

Researchers are evaluating the effects of balcinrenone combined with dapagliflozin compared to dapagliflozin alone in patients who have chronic heart failure, impaired kidney function, and have recently experienced a heart failure event. This Phase III study is conducted internationally across about 700 sites and aims to assess how these treatments impact cardiovascular death and heart failure events. Participants will be randomly assigned to one of three groups balcinrenonedapagliflozin 15 mg10 mg plus placebo, balcinrenonedapagliflozin 40 mg10 mg plus placebo, or dapagliflozin 10 mg plus placebo. Each participant will take one capsule and one tablet daily. The study duration averages 22 months, including screening, about 20 months of blinded treatment, and a one-month follow-up with open-label dapagliflozin. During the study, participants will undergo assessments for heart failure events, hospitalizations, and cardiovascular death. Researchers will monitor these outcomes over about 38 months, including symptom scores and other health measures. Safety and treatment effects will be followed during the treatment and the one-month post-treatment period.