Anand

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.

Researchers are evaluating the effects of baxdrostat combined 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 systolic blood pressure of at least 130 mmHg at screening, and at least one additional risk factor for heart failure. This Phase III randomized, placebo-controlled, event-driven study aims to determine if the combination reduces the risk of heart failure events or cardiovascular death, with follow-up lasting up to 38 months. Participants who meet screening criteria but are not currently treated with SGLT2 inhibitors or have been treated for less than 4 weeks will enter a run-in period receiving dapagliflozin 10 mg once daily for 4 to 6 weeks before randomization. The study involves random assignment to either baxdrostat plus dapagliflozin or placebo plus dapagliflozin. Site visits occur at approximately 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months. Participants discontinuing the blinded study drug may continue open-label dapagliflozin, with ongoing visits and data collection as per protocol. Participants will undergo an optional pre-screening period without site visits or consent to help identify eligibility, followed by up to 14 days of formal screening after informed consent. Researchers will monitor heart failure events and cardiovascular deaths as primary outcomes. Safety and adherence will be tracked throughout the study, including during any premature discontinuation of blinded treatment. The study will conclude when a predetermined number of secondary endpoint events have occurred, with continued follow-up as needed.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.