Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care
Hospital Moinhos de Vento
8,518 participants
Dec 20, 2021
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria4
- 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
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Interventions
Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)
Participants will be randomized to use Stroke Riskometer App for lifestyle modifications
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05155137