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

• Status: Not yet recruiting
• Trial end date: 2026-12-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Moinhos de Vento
• Collaborators: Ministry of Health, Brazil; World Stroke Organization
• Treatments: Amlodipine; Rosuvastatin Calcium; Valsartan

Criteria

Inclusion Criteria:

• adultos 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 (including CHW) that can receive text messages.

Exclusion Criteria:

• Diagnostic of hypercholesterolemia (> 190mg/dL LDL colesterol) or diabetes or take other antihypertensive drugs or open label statins;

• Contraindication to the medication

• Life expecatncy < 5 years

• Participation in another clinical trial