Polypill and Stroke Riskometer to Prevent Stroke and Cognitive Decline in Adults at Low to Moderate Risk in Primary Health Care

What this Trial Is About

Researchers are conducting a phase III clinical trial in Brazil to study whether a polypill containing valsartan, amlodipine, and rosuvastatin, alone or combined with lifestyle changes supported by the Stroke Riskometer app, can reduce stroke and cognitive decline in adults aged 50 to 75 years with low to moderate stroke risk. The study aims to address the gap in current prevention strategies, as most strokes happen in individuals who are not considered high risk. This trial involves 8,518 participants monitored over three years to evaluate these outcomes. The study has two parts: an initial run-in phase where all participants receive the active polypill for 30 days, followed by randomization to receive either the polypill (with dose adjustment of amlodipine if side effects occur) or a placebo. Participants are also randomized to either use the Stroke Riskometer app for lifestyle modifications or receive usual care. Part 1 includes a smaller group in Porto Alegre to assess blood pressure and stroke risk changes over nine months. Part 2 involves the full group across 80 health units in Brazil, with follow-up lasting three years to measure stroke incidence and cognitive decline. Participants will attend regular assessments including blood pressure checks, stroke risk evaluations, and cognitive testing. Researchers will also monitor medication effects, adherence, and any adverse events. The main outcomes measured are stroke occurrence and cognitive decline over three years, with secondary outcomes including heart attack and cardiovascular death rates. Participants need access to a cell phone for study communications and will be followed closely to ensure safety and collect detailed health data throughout the study period.

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