Polipill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Status:
Not yet recruiting
Trial end date:
2026-12-14
Target enrollment:
Participant gender:
Summary
This study is a phase III Randomized Clinical Trial, prospective, placebo controlled of
12,268 subjects with low to moderate risk of stroke followed by 3 years in 60 Primary Health
Care Units in Brazil. The units will be randomized (clusters) to use or not the approach of
community health workers with the Stroke Riskometer. After, patients will be randomized to
receive the polypill (valsartan 80 mg, amlodipine 5 mg and rosuvastatin 10 mg) or placebo
(dose adjustment of amlodipine 2,5 for patients with adverse events). The purpose is to test
whether a polypill alone or in combination with lifestyle modification will reduce the
incidence of stroke and cognitive impairment in this population.
Phase:
Phase 3
Details
Lead Sponsor:
Hospital Moinhos de Vento
Collaborators:
Ministry of Health, Brazil World Stroke Organization