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Study identifier: NCT05155137 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)

Condition: Stroke · Cognitive Decline  ·  Sponsor: Hospital Moinhos de Vento

PhasePhase 3
Planned participants8518
Who can joinAll sexes, 50 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sheila CO Martins, PhD  ·  5551999628467  ·  sheila@redebrasilavc.org.br

Thais L Secchi, MSc  ·  5551998977789  ·  thais.secchi@hmv.org.br

Always discuss trial participation with your own doctor first.

Locations (2)

Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto AlegrePorto Alegre, Rio Grande do Sul, BrazilRecruiting
Hospital Moinhos de VentoPorto Alegre, Rio Grande do Sul, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT05155137