A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial.

BACKGROUND: A cardiovascular polypill containing generic drugs might facilitate sustained implementation of and adherence to evidence-based treatments, especially in resource-limited settings. However, the impact of a cardiovascular polypill in mitigating atherosclerotic risk among stroke survivors has not been assessed. We aimed to compare a polypill regimen with usual care on carotid intima-media thickness (CIMT) regression after ischaemic stroke. METHODS: In SMAART, a phase 2 parallel, open-label, assessor-masked, randomised clinical trial, we randomly allocated individuals (aged ≥18 years) who had an ischaemic stroke within the previous 2 months, using a computer-generated randomisation sequence (1:1), to either a polypill or usual care group at a tertiary centre in Ghana. The polypill regimen was a fixed-dose pill containing 5 mg ramipril, 50 mg atenolol, 12·5 mg hydrochlorothiazide, 20 mg simvastatin, and 100 mg aspirin administered as two capsules once per day for 12 months. Usual care was tailored guideline-recommended secondary prevention medications. The primary outcome was the change in CIMT over 12 months with adjustment for baseline values, compared using ANCOVA in all participants with complete data at month 12. Safety was analysed in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, NCT03329599, and is completed. FINDINGS: Between Feb 12, 2019, and Dec 4, 2020, we randomly assigned 148 participants (74 to the usual care group and 74 to the polypill group), 74 (50%) of whom were male and 74 (50%) female. CIMT was assessed in 62 (84%) of 74 participants in the usual care group and 59 (80%) of 74 participants in the polypill group; the main reason for loss to follow-up was participants not completing the study. The mean CIMT change at month 12 was -0·092 mm (95% CI -0·130 to -0·051) in the usual care group versus -0·017 mm (-0·067 to 0·034) in the polypill group, with an adjusted mean difference of 0·049 (-0·008 to 0·109; p=0·11). Serious adverse events occurred among two (3%) participants in the usual care group, and eight (11%) participants in the polypill group (p=0·049). INTERPRETATION: The polypill regimen resulted in similar regression in subclinical atherosclerosis and many secondary and tertiary outcome measures as the tailored drug regimen, but with more serious adverse events. Larger, longer-term, event-based studies, including patients with stroke in primary care settings, are warranted. FUNDING: US National Institutes of Health. TRANSLATION: For the Akan (Twi) translation of the abstract see Supplementary Materials section.

Prevalence and Predictors of Sleep Apnea Risk among Ghanaian Stroke Survivors.

BACKGROUND AND PURPOSE: Sleep apnea (SA) has emerged as a potent risk factor for stroke recurrence and mortality. The burden of SA among stroke survivors in sub-Saharan Africa where stroke incidence and mortality are escalating is unknown. We sought to assess the prevalence of SA risk and its clinical correlates and predictors among Ghanaian stroke survivors. METHODS: This cross-sectional study involved 200 consecutive stroke survivors attending a neurology clinic in a tertiary medical center in Kumasi, Ghana. The validated Berlin, STOP-BANG, and Epworth Sleepiness Scale questionnaires were administered to all eligible subjects to assess SA risk and daytime somnolence, and their demographic and clinical information, health-related quality of life, and symptoms of depression were collected using the questionnaires. RESULTS: The median (interquartile range) age of stroke survivors was 62 (52-72) years and 52.5% were male. Ninety-nine (49.5%) subjects were identified as high risk for SA using the Berlin questionnaire, whereas 26 (13%), 137 (68.5%), and 37 (18.5%) subjects were classified as low, intermediate, and high risk for SA, respectively, using the STOP-BANG questionnaire. Patients at high risk of SA were significantly older, used excess alcohol, and were less able to perform activities of daily living, although their mean National Institutes of Health Stroke Scale scores were significantly lower than those with low risk for SA. None of the stroke survivors had ever been screened for SA. CONCLUSIONS: One out of every 2 stroke survivors attending a neurology clinic in Ghana is at high risk for undiagnosed SA. Greater regional awareness about SA presence and outcomes among patients and providers is warranted.