MedTrace Logo

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

NCT05155137 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8518

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)

Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)

BEHAVIORAL

Stroke Riskometer

Participants will be randomized to use Stroke Riskometer App for lifestyle modifications

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • World Stroke Organization

    collaborator UNKNOWN

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Sheila CO Martins, PhD · Hospital Moinhos de Vento

  • Michael Brainin, MD · Danube University Krems, Austria

  • Valery Feigin, PhD · AUT University, Oakland, New Zealand

  • Thais L Secchi, MSc · Hospital Moinhos de Vento

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2029-12-14
Completion
2030-12-14

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155137 on ClinicalTrials.gov