6/29/23, 11:45 PM SSaSS Pathway Feedback Search Clinical Topics Home Studies SSaSS SSaSS Disease Disease Acute ischemic stroke Hypertension Trial question Is salt substitution superior to regular salt in patients with a history of stroke? Study design Multi-center Open label RCT Population Characteristics of study participants 50.0% female N = 20995 50.0% male 20995 patients (10393 female, 10602 male) Inclusion criteria: adult participants 60 years of age with a history of stroke and hypertension Key exclusion criteria: participant or family member with a potential contraindication to salt substitute, unlikely to live > 6 months, eats most meals outside home Interventions N=10504 salt substitute (75% sodium chloride and 25% potassium chloride by mass) N=10491 regular salt (100% sodium chloride) Primary outcome Incidence of stroke 33.6/1K py 33.65 https://web.pathway.md/studies/recluf3dW4Al66wZ3 1/2 6/29/23, 11:45 PM py SSaSS Pathway 33 65 29.14 25.2/1K py 16.8/1K py 8.4/1K py Significant decrease 0.0/1K py Salt substitute Regular salt Significant decrease in the incidence of stroke (29.14 events /1000 py vs. 33.65 events /1000 py; RR 0.86, 95% CI 0.77 to 0.96) Secondary outcomes Significant decrease in the incidence of major adverse cardiovascular events (49.09 events /1000 py vs. 56.29 events /1000 py; RR 0.87, 95% CI 0.8 to 0.94) Borderline significant decrease in the incidence of death from vascular causes (22.9 events /1000 py vs. 26.3 events /1000 py; RR 0.87, 95% CI 0.79 to 0.96) Safety outcomes No significant difference in clinical hyperkalemia. Conclusion In adult participants 60 years of age with a history of stroke and hypertension, salt substitute was superior to regular salt with respect to the incidence of stroke. Reference Bruce Neal, Yangfeng Wu, Xiangxian Feng et al. Effect of Salt Substitution on Cardiovascular Events and Death. N Engl J Med. 2021 Sep 16;385(12):1067-1077. Open reference URL https://web.pathway.md/studies/recluf3dW4Al66wZ3 2/2