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Published on: January 11, 2020
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Polypill and Riskometer to Prevent Stroke and Cognitive Impairment in Primary Health Care (PROMOTE) Randomized
Michael Brainin1,2, Craig S Anderson3, Philip M Bath4,5
1Neurology, Hospital Moinhos de Vento, Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Neuroepidemiology
|August 28, 2025
Summary
This study evaluated a polypill and app for preventing stroke and cardiovascular disease in adults at low risk. Results will inform primary prevention strategies for broader populations.
Area of Science:
- Cardiovascular Medicine
- Public Health
- Preventive Cardiology
Background:
- Stroke and dementia share modifiable risk factors, yet prevention often targets high-risk groups.
- A gap exists in primary prevention strategies for the broader low to borderline cardiovascular disease (CVD) risk population.
Purpose of the Study:
- To assess the feasibility, tolerability, and effectiveness of a polypill (valsartan, amlodipine, rosuvastatin) combined with the Stroke Riskometer app.
- To evaluate the impact on systolic blood pressure (SBP) and other CVD risk factors over 9 months in low to borderline CVD risk individuals.
Main Methods:
- A prospective, pragmatic, multicentre, factorial, phase III, placebo-controlled, cluster randomized controlled trial (RCT).
- Inclusion criteria: 50-75 years, 10-year CVD risk <20%, SBP 121-139 mmHg, and at least one lifestyle risk factor.
- Participants received a polypill or placebo, with or without the Stroke Riskometer app, with primary outcomes being change in SBP and Life Simple 7 (LS7) score.
Main Results:
- The study protocol is designed to detect a clinically significant difference in SBP and LS7 score changes.
- Intention-to-treat analysis will compare outcomes between the polypill/app group and placebo/usual care group.
- Regression models will assess changes in SBP, cholesterol, cognitive function, and behavioral risk factors.
Conclusions:
- Findings will inform primary stroke and CVD prevention strategies for adults at low to borderline CVD risk.
- This research addresses a critical need for population-wide preventive measures.
- Trial registration: clinicaltrials.gov NCT05155137.
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