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Clinical Trials in Brazil / NCT05155137
Recruiting Phase 3

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

NCT05155137 · tracked via the Priya Life Science Brazil tracker
Sponsor
Hospital Moinhos de Vento
Phase
Phase 3
Started
2021-12-20
Last updated
2025-01-23

Condition(s) studied

StrokeCognitive Decline

Investigational drug(s) / intervention(s)

Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)All Amlodipine trials (10) →All Rosuvastatin trials (32) →Stroke Riskometer

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

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

Study summary

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

Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Hospital Moinhos de Vento Porto Alegre Rio Grande do Sul Recruiting

More Hospital Moinhos de Vento trials in Brazil

Neuromuscular Electrical Stimulation in a Patient on Invasive Mechanical Ventilation (MOVCARE) Recruiting
Randomization to Endovascular Treatment Alone or Preceded by Systemic Thrombolysis With Tenecteplase in Ischemic Stroke Recruiting
Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population Active, not recruiting
Onco-Genomas Brasil: Mapping Breast and Prostate Cancer in the Brazilian Public Health System Active, not recruiting
Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT Recruiting

Other trials for the same condition

Vivifrail Exercise Program in Nonagenarians: Effects on Function, Muscle, and Cognition Enrolling by invitation
Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults Recruiting
EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction Active, not recruiting
Efficacy of Trans-auricular Vagus Nerve Stimulation on Upper Extremity Motor Recovery in Stroke Survivors Recruiting
Biofeedback After Stroke Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05155137 on ClinicalTrials.gov ↗ ← All trials in Brazil