Health TrialsbyHealthPanel

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

ConditionsStrokeCognitive Decline
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-75
SponsorHospital Moinhos de Vento

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)

    Drug

    Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)

  • Stroke Riskometer

    Behavioral

    Participants will be randomized to use Stroke Riskometer App for lifestyle modifications

Treatment groups

8,518 Participants
are divided into 4 treatment groups
Group A: Polypill + Stroke RiskometerExperimental treatment 2 interventions
Group B: Placebo + Stroke RiskometerPlacebo comparator 1 intervention
Group C: Polypill + No Stroke Riskometer (Usual care)Experimental treatment 1 intervention
Group D: Placebo + No Riskometer (Usual Care)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Stroke

Incidence of Ischemic or hemorrhagic stroke

Time frame
3 years
2

Cognitive decline

Cognitive decline rate

Time frame
3 years

Secondary outcomes

1

MACE

Incidence of Stroke/TIA, Myocardial infarction, hospitalization for cardiovascular cause and cardiovascular death comparing the polypill and placebo group and comparing riskometer and no riskometer group

Time frame
3 years
2

Life's Essential 8 Score (LE8)

Difference of LE8 at the baseline and in 3 years comparing the 4 groups

Time frame
3 years
3

Systolic blood pressure

Systolic blood pressure in 3 years comparing the 4 groups

Time frame
3 years
4

Cholesterol

Total and LDL cholesterol in 3 years comparing the 4 groups

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Moinhos de Vento

Lead sponsor

Ministry of Health, Brazil

Collaborator

World Stroke Organization

Collaborator

Source ClinicalTrials.gov
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