Polipill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE) — PROMOTE  

Stroke Clinical Trial

Official title: Polipill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care

Status Recruiting

Clinical Trial Summary

This study is a phase III Randomized Clinical Trial, prospective, placebo controlled of 12,268 subjects with low to moderate risk of stroke followed by 3 years in 60 Primary Health Care Units in Brazil. The units will be randomized (clusters) to use or not the approach of community health workers with the Stroke Riskometer. After, patients will be randomized to receive the polypill (valsartan 80 mg, amlodipine 5 mg and rosuvastatin 10 mg) or placebo (dose adjustment of amlodipine 2,5 for patients with adverse events). The purpose is to test whether a polypill alone or in combination with lifestyle modification will reduce the incidence of stroke and cognitive impairment in this population.

Clinical Trial Description

Background and Aims The increase burden of stroke and dementia provides strong evidence that currently used primary prevention strategies are not enough and 80% of strokes occur in people with low to moderate risk. The purpose is to test whether a polypill used alone or in combination with lifestyle modification will reduce the incidence of stroke and cognitive impairment in a population of individuals with low to moderate risk of stroke.

Methods

Phase III Randomized Clinical Trial, prospective, placebo controlled of 12,268 subjects followed by 3 years. 60 Health Units in Brazil will be randomized (clusters) to use or not the approach of community health workers with the Stroke Riskometer. After a run-in phase (30 days, all participants with active drug), patients will be randomized to receive the polypill (valsartan 80 mg, amlodipine 5 mg and rosuvastatin 10 mg) or placebo (dose adjustment of amlodipine 2,5 for patients with adverse events). It will be included: (1)adults aged 50-75 years; (2) no previous history of stroke, TIA or cardiovascular disease; (3)systolic blood pressure (BP) 121-139 mmHg; (4) one or more lifestyle risk factors (smoking, overweight, physical inactivity or inadequate diet. It will be excluded patients with hypercholesterolemia or diabetes or take other antihypertensive drugs or open label statins. Subjects will be randomized under a minimization process:

Minimization factors:

• Age: 50-64 vs 65-75

• Sex: men vs women

• BP: 121-130 vs 131-139

• Education level: <5 years vs > 5 years

• Total Cholesterol: <5 mmol (194 mg/dl) vs <5 mmol (194 mg/dl)

The study will be conducted in 2 parts:

Part 1. 10 Family Health Strategy Units (10 clusters) located in Porto Alegre will be eligible to participate in part 1, which will assess surrogate endpoints in 1000 patients included in the study in 9 months (blood pressure reduction and change in stroke risk by the scale LS7). Also we will evaluate the strategies, and barriers for implementation and adverse events.

Part 2. 60 Family Health Strategy Units in the 5 Brazilian regions, 12,268 participants followed for 3 years measuring stroke incidence and cognitive decline rate as the primary outcome. Expected results in primary outcome: to reduce the incidence of stroke and cognitive decline in the group of polypill and / or polypill + Riskometer. Secondary outcome: to reduce stroke, MI and cardiovascular death. The results of the first part will be used to review the sample size. ;

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Stroke

• NCT number: NCT05155137
• Study type: Interventional
• Source: Hospital Moinhos de Vento
• Contact: Sheila CO Martins, PhD
• Phone: 5551999628467
• Email: sheila@redebrasilavc.org.br
• Status: Recruiting
• Phase: Phase 3
• Start date: December 20, 2021
• Completion date: December 14, 2026