Clinical Trial

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

Study acronym: PROMOTE

Recruiting Phase 3

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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2021-12-10; most recent amendment 2025-01-20.

Status change: Not Yet Recruiting → Recruiting 2022-01-13

Trial Details

NCT Number	NCT05155137
Lead Sponsor	Hospital Moinhos de Vento Collaborators: Ministry of Health, Brazil, World Stroke Organization
Conditions	Stroke, Cognitive Decline
Enrollment	8,518 participants
Start Date	2021-12-20
Primary Completion	2029-12-14 (estimated)
Study Completion	2030-12-14 (estimated)
Updated on ClinicalTrials.gov	2025-01-23