Safety and efficacy of sovateltide in acute cerebral ischemic stroke patients at a tertiary care centre-a double blinded block randomised placebo controlled study

Stroke is the second most common cause of death in our country and is also an important factor which causes a serious long-lasting disability where care giver’s burden is very high. The foremost treatment strategies available currently for acute cerebral ischemic stroke includes thrombolysis by administrating tissue plasminogen activator (tPA) and mechanical thrombectomy. However, both these strategies have a short time window. Limitations of time, risk of bleeding and involvement of larger blood vessels for thrombectomy restricts current treatment to only about 5% of patients. Sovateltide or IRL-1620 is a synthetic analog of endothelin 1 (ET-1). Sovateltide is a selective agonist of endothelin B (ETBRs). ETBRs play an important role in neural cell survival and proliferation. Sovateltide, administered intravenously following acute cerebral ischemic stroke increased cerebral blood flow, had anti-apoptotic activity and produced neurovascular remodelling. Hence, this study is designed to determine the efficacy of Sovateltide along with standard of care stroke protocol in improving the 90th day quality of life in acute cerebral ischemic stroke patients presenting within 24 hours of stroke onset as measured using modified rankin scale (MRS) and national institute of health stroke scale (NIHSS) compared to standard of care stroke protocol alone. Our sample size is 60 with 30 patients in the treatment group and 30 patients in the placebo group respectively. Patients who fulfil the inclusion criteria will be randomised into both the arms. Treatment group will receive three doses of sovateltide (each dose 0.3 µg/kg) administered as an intravenous bolus over 1 min at an interval of 3 hours on day 1, day 3 and day 6 (total dose of 0.9 µg/kg/day). The other group will receive a matching placebo at the same dose and on the same dose intervals. The study duration for each patient will be 3 months (90 days), which includes three follow-up visits: visit 1 (day 15, screening/baseline measurements/treatment/assessment), visit 2 (day 90 for final MR score/ NIHS score (day 90 ± 5 days, assessment). All patients will be monitored closely throughout hospitalization and will be followed-up for 90 days from randomization.