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

Launched by HOSPITAL MOINHOS DE VENTO · Dec 10, 2021

Keywords

ClinConnect Summary

The PROMOTE trial is studying whether a special combination pill, known as a polypill, can help prevent strokes and cognitive decline (which means problems with memory and thinking) in adults aged 50 to 75 who are at low to moderate risk for these conditions. The trial will involve over 12,000 participants from 60 health care units in Brazil. Some of the health care units will use a tool called the Stroke Riskometer, which helps assess stroke risk, while others will not. Participants will then be randomly assigned to receive either the polypill, which contains three medications to help manage blood pressure and cholesterol, or a placebo (a dummy pill that looks the same but has no active ingredients).

To be eligible for this study, individuals must be between 50 and 75 years old, have no history of stroke or heart disease, have slightly elevated blood pressure, and have at least one lifestyle risk factor like being overweight or not getting enough exercise. Importantly, participants will need access to a cell phone for communication. Throughout the study, participants will be monitored for any changes in their health over three years, and they will receive support for healthy lifestyle changes. This trial is currently recruiting participants who meet these criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • adults aged 50-75 years;
• • no previous history of stroke, TIA or cardiovascular disease;
• • systolic blood pressure (SBP) 121-139 mmHg;
• • with one or more lifestyle risk factors: smoking, overweight (BMI\> 25 kg / m2), physical inactivity (WHO criteria for aerobic physical activity \<150 minutes / week or at least 75 minutes of aerobic physical activity of vigorous intensity during the week or an equivalent combination of activity of moderate and vigorous intensity) or inadequate diet / poor eating habits (low intake of fruits and vegetables, fish, whole grains, high intake of drinks sweetened with sodium and sugar)
• • owns or has access to a cell phone that can receive text messages.
• Exclusion Criteria:
• • Diagnostic of hypercholesterolemia (\> 190mg/dL LDL cholesterol) or diabetes or take other antihypertensive drugs or open label statins;
• • Contraindication to the medication
• • Life expectancy \< 5 years
• • Participation in another clinical trial