Using a polypill and lifestyle changes to prevent stroke and cognitive decline
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care
This study is testing whether a combination of a polypill and lifestyle changes can help people aged 50-75 in Brazil lower their risk of stroke and memory problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 8518 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Moinhos de Vento Academic / other |
| Locations | 2 sites (Porto Alegre, Rio Grande do Sul and 1 other locations) |
| Trial ID | NCT05155137 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50-75 with low to moderate stroke risk and one or more lifestyle risk factors.
Not a fit: Patients with a history of stroke, cardiovascular disease, diabetes, or hypercholesterolemia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of stroke and cognitive decline in at-risk populations.
How similar studies have performed: Previous studies have shown promise in using polypills for cardiovascular prevention, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Porto Alegre, Rio Grande do Sul and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.