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Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Sponsor: Hospital Moinhos de Vento
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.
Official title: Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
8518
Start Date
2021-12-20
Completion Date
2030-12-14
Last Updated
2025-01-23
Healthy Volunteers
No
Conditions
Interventions
Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)
Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)
Stroke Riskometer
Participants will be randomized to use Stroke Riskometer App for lifestyle modifications
Locations (2)
Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil