Tests a polypill and lifestyle tool to prevent stroke and memory decline
Tests a daily pill combination against placebo in adults with low to moderate stroke risk.
Plain-language title generated from the registry record
Registry title: Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Key facts
- Where
- Porto Alegre, BrazilSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 75 years old?
Source: NCT05155137, who can take part
Where in Brazil
- Hospital Moinhos de VentoPorto Alegre, BrazilTaking people
- Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto AlegrePorto Alegre, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Moinhos de Vento
- Trial code
- NCT05155137
- Record updated
- 23 January 2025
- Original description
This study is a phase III, prospective, placebo-controlled randomized clinical trial involving 8,518 subjects with low to moderate stroke risk, followed for 3 years in Brazil. Participants will be randomized to receive either the polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg), with dose adjustment of amlodipine to 2.5 mg for patients experiencing adverse events, or a placebo, and to either use the Stroke Riskometer for lifestyle modification or receive usual care. The purpose of the study is to test whether the polypill, alone or in combination with lifestyle modification, will reduce the incidence of stroke and cognitive impairment in this population.Read full original descriptionShow less
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care
This study is a phase III, prospective, placebo-controlled randomized clinical trial involving 8,518 subjects with low to moderate stroke risk, followed for 3 years in Brazil. Participants will be randomized to receive either the polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg), with dose adjustment of amlodipine to 2.5 mg for patients experiencing adverse events, or a placebo, and to either use the Stroke Riskometer for lifestyle modification or receive usual care. The purpose of the study is to test whether the polypill, alone or in combination with lifestyle modification, will reduce the incidence of stroke and cognitive impairment in this population.
Inclusion: 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: Contraindication to the medication; Diagnostic of hypercholesterolemia (> 190mg/dL LDL cholesterol) or diabetes or take other antihypertensive drugs or open label statins; Life expectancy < 5 years; Participation in another clinical trial.