AzTrials
AzTrials

StrokePhase 3PROMOTENCT05155137

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

A Phase 3 study testing Drug Capsule (Valsartan + Amlodipine + Rosuvastatin) and Stroke Riskometer in people with Stroke and Cognitive Decline, run by Hospital Moinhos de Vento at 2 sites in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Stroke, Cognitive Decline
What is being tested?
Drug Capsule (Valsartan + Amlodipine + Rosuvastatin) and Stroke Riskometer
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,518 participants
Where
2 sitesBrazil
Study dates
20 Dec 2021to 14 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sheila CO Martins, PhD contact

5551999628467

sheila@redebrasilavc.org.br

Thais L Secchi, MSc contact

5551998977789

thais.secchi@hmv.org.br

Brazil2 sites, 2 recruiting

  • Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90620-110

    Luiz A Nasi, PhD

    Recruiting

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul

    Sheila Martins, PhD

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Drug Capsule (Valsartan + Amlodipine + Rosuvastatin), Stroke Riskometer
Keywords
stroke, cognitive decline, prevention, polypill, stroke riskometer, primary care
Medical subject headings
Stroke, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)Drug

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

  • Stroke RiskometerBehavioural

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

Study groups in NCT05155137
Study groupRoleWhat they receive
Polypill + Stroke RiskometerExperimentalParticipants 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
Receives: Drug: Drug Capsule (Valsartan + Amlodipine + Rosuvastatin); Behavioral: Stroke Riskometer
Placebo + Stroke RiskometerPlacebo comparatorParticipants will be randomized to use placebo polypill and to use the Stroke Riskometer for lifestyle modification
Receives: Behavioral: Stroke Riskometer
Polypill + No Stroke Riskometer (Usual care)ExperimentalParticipants 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
Receives: Drug: Drug Capsule (Valsartan + Amlodipine + Rosuvastatin)
Placebo + No Riskometer (Usual Care)No interventionParticipants will be randomized to use placebo polypill and will not use the Stroke Riskometer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stroke

    Incidence of Ischemic or hemorrhagic stroke

    Measured: 3 years

  2. Cognitive decline

    Cognitive decline rate

    Measured: 3 years

Secondary outcomes (8)

  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

    Measured: 3 years

  2. Life's Essential 8 Score (LE8)

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

    Measured: 3 years

  3. Systolic blood pressure

    Systolic blood pressure in 3 years comparing the 4 groups

    Measured: 3 years

  4. Cholesterol

    Total and LDL cholesterol in 3 years comparing the 4 groups

    Measured: 3 years

  5. Numbers of Cardiovascular risk factors

    Numbers of Cardiovascular risk factors in the riskometer group comparing to the usual care

    Measured: 3 years

  6. Quality of Life Analysis

    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

    Measured: 3 years

  7. Life's Essential 8 Score (LE8)

    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

    Measured: 3 years

  8. Cost of stroke treatment

    Cost of primary care in the primary care unit

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start20 Dec 2021
  3. Primary completion14 Dec 2029 (estimated)
  4. Study completion14 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase III, prospective, placebo-controlled randomized clinical trial involving 8,518 individuals in 80 Primary Care Health Units. Participants will be randomized into four groups: 1) Polypill (valsartan 80 mg, amlodipine 5 mg, and rosuvastatin 10 mg) + Stroke Riskometer, 2) Placebo + Stroke Riskometer, 3) Polypill + Usual care, and 4) Placebo + Usual care.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,518 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155137
Sponsor's protocol ID
41456820.6.1001.5330
Acronym
PROMOTE
Status last verified
Jan 2025
First submitted
30 Nov 2021
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.

    PubMed 28931491

  • Feigin VL, Roth GA, Naghavi M, Parmar P, Krishnamurthi R, Chugh S, Mensah GA, Norrving B, Shiue I, Ng M, Estep K, Cercy K, Murray CJL, Forouzanfar MH; Global Burden of Diseases, Injuries and Risk Factors Study 2013 and Stroke Experts Writing Group. Global burden of stroke and risk factors in 188 countries, during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet Neurol. 2016 Aug;15(9):913-924. doi: 10.1016/S1474-4422(16)30073-4. Epub 2016 Jun 9.

    PubMed 27291521

  • The Lancet Neurology. The shared burden of stroke and dementia. Lancet Neurol. 2016 Aug;15(9):891. doi: 10.1016/S1474-4422(16)30132-6. No abstract available.

    PubMed 27478943

  • Feigin VL, Norrving B, George MG, Foltz JL, Roth GA, Mensah GA. Prevention of stroke: a strategic global imperative. Nat Rev Neurol. 2016 Sep;12(9):501-12. doi: 10.1038/nrneurol.2016.107. Epub 2016 Jul 22.

    PubMed 27448185

  • Forouzanfar MH, Liu P, Roth GA, Ng M, Biryukov S, Marczak L, Alexander L, Estep K, Hassen Abate K, Akinyemiju TF, Ali R, Alvis-Guzman N, Azzopardi P, Banerjee A, Barnighausen T, Basu A, Bekele T, Bennett DA, Biadgilign S, Catala-Lopez F, Feigin VL, Fernandes JC, Fischer F, Gebru AA, Gona P, Gupta R, Hankey GJ, Jonas JB, Judd SE, Khang YH, Khosravi A, Kim YJ, Kimokoti RW, Kokubo Y, Kolte D, Lopez A, Lotufo PA, Malekzadeh R, Melaku YA, Mensah GA, Misganaw A, Mokdad AH, Moran AE, Nawaz H, Neal B, Ngalesoni FN, Ohkubo T, Pourmalek F, Rafay A, Rai RK, Rojas-Rueda D, Sampson UK, Santos IS, Sawhney M, Schutte AE, Sepanlou SG, Shifa GT, Shiue I, Tedla BA, Thrift AG, Tonelli M, Truelsen T, Tsilimparis N, Ukwaja KN, Uthman OA, Vasankari T, Venketasubramanian N, Vlassov VV, Vos T, Westerman R, Yan LL, Yano Y, Yonemoto N, Zaki ME, Murray CJ. Global Burden of Hypertension and Systolic Blood Pressure of at Least 110 to 115 mm Hg, 1990-2015. JAMA. 2017 Jan 10;317(2):165-182. doi: 10.1001/jama.2016.19043.

    PubMed 28097354

  • Farzadfar F, Finucane MM, Danaei G, Pelizzari PM, Cowan MJ, Paciorek CJ, Singh GM, Lin JK, Stevens GA, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Cholesterol). National, regional, and global trends in serum total cholesterol since 1980: systematic analysis of health examination surveys and epidemiological studies with 321 country-years and 3.0 million participants. Lancet. 2011 Feb 12;377(9765):578-86. doi: 10.1016/S0140-6736(10)62038-7. Epub 2011 Feb 3.

    PubMed 21295847

  • O'Regan C, Wu P, Arora P, Perri D, Mills EJ. Statin therapy in stroke prevention: a meta-analysis involving 121,000 patients. Am J Med. 2008 Jan;121(1):24-33. doi: 10.1016/j.amjmed.2007.06.033.

    PubMed 18187070

  • Feigin VL, Norrving B, Mensah GA. Primary prevention of cardiovascular disease through population-wide motivational strategies: insights from using smartphones in stroke prevention. BMJ Glob Health. 2017 Apr 4;2(2):e000306. doi: 10.1136/bmjgh-2017-000306. eCollection 2016.

    PubMed 28589034

  • Yusuf S, Lonn E, Pais P, Bosch J, Lopez-Jaramillo P, Zhu J, Xavier D, Avezum A, Leiter LA, Piegas LS, Parkhomenko A, Keltai M, Keltai K, Sliwa K, Chazova I, Peters RJ, Held C, Yusoff K, Lewis BS, Jansky P, Khunti K, Toff WD, Reid CM, Varigos J, Accini JL, McKelvie R, Pogue J, Jung H, Liu L, Diaz R, Dans A, Dagenais G; HOPE-3 Investigators. Blood-Pressure and Cholesterol Lowering in Persons without Cardiovascular Disease. N Engl J Med. 2016 May 26;374(21):2032-43. doi: 10.1056/NEJMoa1600177. Epub 2016 Apr 2.

    PubMed 27039945

  • Brainin M, Feigin V, Martins S, Matz K, Roy J, Sandercock P, Teuschl Y, Tuomilehto J, Wiseman A. Cut stroke in half: Polypill for primary prevention in stroke. Int J Stroke. 2018 Aug;13(6):633-647. doi: 10.1177/1747493018761190. Epub 2018 Feb 20.

    PubMed 29461155

  • Elley CR, Gupta AK, Webster R, Selak V, Jun M, Patel A, Rodgers A, Thom S. The efficacy and tolerability of 'polypills': meta-analysis of randomised controlled trials. PLoS One. 2012;7(12):e52145. doi: 10.1371/journal.pone.0052145. Epub 2012 Dec 19.

    PubMed 23284906

  • Roshandel G, Khoshnia M, Poustchi H, Hemming K, Kamangar F, Gharavi A, Ostovaneh MR, Nateghi A, Majed M, Navabakhsh B, Merat S, Pourshams A, Nalini M, Malekzadeh F, Sadeghi M, Mohammadifard N, Sarrafzadegan N, Naemi-Tabiei M, Fazel A, Brennan P, Etemadi A, Boffetta P, Thomas N, Marshall T, Cheng KK, Malekzadeh R. Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial. Lancet. 2019 Aug 24;394(10199):672-683. doi: 10.1016/S0140-6736(19)31791-X.

    PubMed 31448738

  • Sung J, Jeong JO, Kwon SU, Won KH, Kim BJ, Cho BR, Kim MK, Lee S, Kim HJ, Lim SH, Park SW, Park JE. Valsartan 160 mg/Amlodipine 5 mg Combination Therapy versus Amlodipine 10 mg in Hypertensive Patients with Inadequate Response to Amlodipine 5 mg Monotherapy. Korean Circ J. 2016 Mar;46(2):222-8. doi: 10.4070/kcj.2016.46.2.222. Epub 2016 Mar 21.

    PubMed 27014353

  • Brainin M, Feigin V, Bath PM, Collantes E, Martins S, Pandian J, Sacco R, Teuschl Y. Multi-level community interventions for primary stroke prevention: A conceptual approach by the World Stroke Organization. Int J Stroke. 2019 Oct;14(8):818-825. doi: 10.1177/1747493019873706. Epub 2019 Sep 9.

    PubMed 31500553

  • Parmar P, Krishnamurthi R, Ikram MA, Hofman A, Mirza SS, Varakin Y, Kravchenko M, Piradov M, Thrift AG, Norrving B, Wang W, Mandal DK, Barker-Collo S, Sahathevan R, Davis S, Saposnik G, Kivipelto M, Sindi S, Bornstein NM, Giroud M, Bejot Y, Brainin M, Poulton R, Narayan KM, Correia M, Freire A, Kokubo Y, Wiebers D, Mensah G, BinDhim NF, Barber PA, Pandian JD, Hankey GJ, Mehndiratta MM, Azhagammal S, Ibrahim NM, Abbott M, Rush E, Hume P, Hussein T, Bhattacharjee R, Purohit M, Feigin VL; Stroke RiskometerTM Collaboration Writing Group. The Stroke Riskometer(TM) App: validation of a data collection tool and stroke risk predictor. Int J Stroke. 2015 Feb;10(2):231-44. doi: 10.1111/ijs.12411. Epub 2014 Dec 10.

    PubMed 25491651

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug Capsule (Valsartan + Amlodipine + Rosuvastatin) and Stroke Riskometer in people with Stroke and Cognitive Decline, run by Hospital Moinhos de Vento at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sheila CO Martins, PhD (5551999628467, sheila@redebrasilavc.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155137, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
PROMOTE Clinical Trial NCT05155137 | AzTrials