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

January 20, 2025 updated by: Hospital Moinhos de Vento

Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt in Primary Health Care

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Aims The increasing burden of stroke and dementia provides strong evidence that current primary prevention strategies are insufficient, as 80% of strokes occur in individuals with low to moderate risk. The purpose of this study 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 with low to moderate stroke risk.

Methods

This is a phase III, multicenter, prospective, double-blind, placebo-controlled randomized clinical trial of 8,518 subjects with low to moderate stroke risk, followed for 3 years. The study will include 80 Health Units affiliated with 20 research centers in Brazil. After a run-in phase (30 days, all participants with active drug), participants will be randomized to receive either the polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg) or a placebo (with dose adjustment of amlodipine to 2.5 mg for patients experiencing adverse events), and to either use the Stroke Riskometer for lifestyle modification or receive usual care. 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:

  • 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. Family Health Strategy Units (10 clusters) located in Porto Alegre will be eligible to participate in part 1, which will assess surrogate endpoints in 370 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. 80 Family Health Strategy Units, affiliated with 20 research centers, in the 5 Brazilian regions, 8,518 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.

Study Type

Interventional

Enrollment (Estimated)

8518

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Recruiting
        • Hospital Moinhos de Vento
        • Contact:
          • Sheila Martins, PhD
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90620-110
        • Recruiting
        • Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre
        • Contact:
          • Luiz A Nasi, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polypill + Stroke Riskometer
Participants will be randomized to use the active polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg) and to use the Stroke Riskometer for lifestyle modification
Drug: Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)
Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)
Behavioral: Stroke Riskometer
Participants will be randomized to use Stroke Riskometer App for lifestyle modifications
Placebo Comparator: Placebo + Stroke Riskometer
Participants will be randomized to use placebo polypill and to use the Stroke Riskometer for lifestyle modification
Behavioral: Stroke Riskometer
Participants will be randomized to use Stroke Riskometer App for lifestyle modifications
Experimental: Polypill + No Stroke Riskometer (Usual care)
Participants will be randomized to use the active polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg) and will not use the Stroke Riskometer
Drug: Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)
Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)
No Intervention: Placebo + No Riskometer (Usual Care)
Participants will be randomized to use placebo polypill and will not use the Stroke Riskometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive decline
Time Frame: 3 years
Cognitive decline rate
3 years
Stroke
Time Frame: 3 years
Incidence of Ischemic or hemorrhagic stroke
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 3 years
Systolic blood pressure in 3 years comparing the 4 groups
3 years
Cholesterol
Time Frame: 3 years
Total and LDL cholesterol in 3 years comparing the 4 groups
3 years
Quality of Life Analysis
Time Frame: 3 years
Quality of life analysis as measured by EuroQol/EQ5D comparing the 4 groups. The score range from 0.33 to 1 with higher scores indicating better quality if life
3 years
Cost of stroke treatment
Time Frame: 3 years
Cost of primary care in the primary care unit
3 years
MACE
Time Frame: 3 years
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
3 years
Life's Essential 8 Score (LE8)
Time Frame: 3 years
Difference of LE8 at the baseline and in 3 years comparing the 4 groups
3 years
Numbers of Cardiovascular risk factors
Time Frame: 3 years
Numbers of Cardiovascular risk factors in the riskometer group comparing to the usual care
3 years
Life's Essential 8 Score (LE8)
Time Frame: 3 years
Proportion of participants with decreased risk for LE8 comparing the 4 groups. The score range from 0 to 100 with higher scores indicating better cardiovascular health
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Moinhos de Vento

Collaborators

Ministry of Health, Brazil
World Stroke Organization

Investigators

  • Principal Investigator: Sheila CO Martins, PhD, Hospital Moinhos de Vento
  • Study Chair: Michael Brainin, MD, Danube University Krems, Austria
  • Study Chair: Valery Feigin, PhD, AUT University, Oakland, New Zealand
  • Study Director: Thais L Secchi, MSc, Hospital Moinhos de Vento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Estimated)

December 14, 2029

Study Completion (Estimated)

December 14, 2030

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 13, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41456820.6.1001.5330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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