Abstract Number: Esoc2026lb174 Intensive Blood-Pressure Control for the Prevention of Major Cardiovascular Events in Stroke Patients: Rational, Design and Baseline Characteristics of the Optimal-Stroke Trial

Abstract Background and aims Effective targets for systolic blood-pressure (SBP) control in patients with ischemic stroke (IS) remain unclear. The OPTIMAL-STROKE trial aims to determine whether an intensive blood pressure reduction strategy (target SBP 120 mmHg), compared with a standard treatment strategy (target SBP 140 mmHg), reduces major cardiovascular events in patients with prior IS or transient ischemic attack (TIA). Methods OPTIMAL-STROKE is a multicenter, randomized, parallel-group, open-label trial with blinded endpoint evaluation. Clinically stable patients with elevated SBP (130–180 mmHg) and a prior history of IS or TIA were randomized 1:1, using a centralized concealed system, to intensive or standard blood pressure treatment for up to 48 months. The primary outcome is a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or heart failure. Outcomes were adjudicated by an independent blinded committee. Analyses will follow the intention-to-treat principle. Results From August 2019 to August 2022, 4,368 patients from 30 sites in Brazil were enrolled, 91.7% with prior IS. The mean age was 63.93 ± 11.21 years, and 47.9% were women. Median time from qualifying event to randomization was 1.12 years (IQR, 0.25–3.84). Among randomized patients, 40.3% had diabetes, 84.7% dyslipidemia, 15,3% coronary artery disease, and 8.7% atrial fibrillation. Mean baseline SBP was 146.71 ±12.64 mmHg. Baseline data current as of 02/12/2026. Conclusions OPTIMAL-STROKE will provide insight into the optimal blood pressure targets for patients with hypertension and IS or TIA. It represents the largest randomized clinical trial to investigate this research question to date. Trial registration : ClinicalTrials.gov-NCT04036409 Conflict of interest