Using a polypill and lifestyle changes to prevent stroke and cognitive decline

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial involves 8,518 participants aged 50-75 with low to moderate stroke risk in Brazil. Participants will be randomized to receive either a polypill containing valsartan, amlodipine, and rosuvastatin or a placebo, along with either lifestyle modification support through the Stroke Riskometer or usual care. The study aims to determine if this combination can effectively reduce the incidence of stroke and cognitive impairment over a three-year follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* adults aged 50-75 years;
* no previous history of stroke, TIA or cardiovascular disease;
* systolic blood pressure (SBP) 121-139 mmHg;
* with one or more lifestyle risk factors: smoking, overweight (BMI\> 25 kg / m2), physical inactivity (WHO criteria for aerobic physical activity \<150 minutes / week or at least 75 minutes of aerobic physical activity of vigorous intensity during the week or an equivalent combination of activity of moderate and vigorous intensity) or inadequate diet / poor eating habits (low intake of fruits and vegetables, fish, whole grains, high intake of drinks sweetened with sodium and sugar)
* owns or has access to a cell phone that can receive text messages.

Exclusion Criteria:

* Diagnostic of hypercholesterolemia (\> 190mg/dL LDL cholesterol) or diabetes or take other antihypertensive drugs or open label statins;
* Contraindication to the medication
* Life expectancy \< 5 years
* Participation in another clinical trial

Where it's running

• Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Hospital Moinhos de Vento
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting

Study contacts

• Principal investigator: Sheila CO Martins, PhD — Hospital Moinhos de Vento
• Study coordinator: Sheila CO Martins, PhD
• Email: sheila@redebrasilavc.org.br
• Phone: 5551999628467

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.