Actively Recruiting
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Led by Hospital Moinhos de Vento · Updated on 2025-01-23
8518
Participants Needed
2
Research Sites
468 weeks
Total Duration
On this page
Sponsors
H
Hospital Moinhos de Vento
Lead Sponsor
M
Ministry of Health, Brazil
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50-75 years
- No previous history of stroke, transient ischemic attack, or cardiovascular disease
- Systolic blood pressure between 121 and 139 mmHg
- One or more lifestyle risk factors such as smoking, overweight (BMI > 25 kg/m2), physical inactivity, or poor diet
- Owns or has access to a cell phone that can receive text messages
You will not qualify if you...
- Diagnosis of hypercholesterolemia (LDL cholesterol > 190 mg/dL) or diabetes
- Taking other antihypertensive drugs or open-label statins
- Contraindications to the study medication
- Life expectancy less than 5 years
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90620-110
Actively Recruiting
2
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
Research Team
S
Sheila CO Martins, PhD
CONTACT
T
Thais L Secchi, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here