Polypill and RiscOMeter to Prevent StrOke and CogniTive ImpairmEnt (PROMOTE)
NCT ID: NCT05155137
Last Updated: 2025-01-23
Study Results
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Basic Information
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RECRUITING
PHASE3
8518 participants
INTERVENTIONAL
2021-12-20
2030-12-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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 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
Placebo + Stroke Riskometer
Participants will be randomized to use placebo polypill and to use the Stroke Riskometer for lifestyle modification
Stroke Riskometer
Participants will be randomized to use Stroke Riskometer App for lifestyle modifications
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 Capsule (Valsartan + Amlodipine + Rosuvastatin)
Polypill with 3 medications (Valsartan 80 mg + Amlodipine 5 mg + Rosuvastatin 10 mg)
Placebo + No Riskometer (Usual Care)
Participants will be randomized to use placebo polypill and will not use the Stroke Riskometer
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Contraindication to the medication
* Life expectancy \< 5 years
* Participation in another clinical trial
50 Years
75 Years
ALL
No
Sponsors
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Ministry of Health, Brazil
OTHER_GOV
World Stroke Organization
UNKNOWN
Hospital Moinhos de Vento
OTHER
Responsible Party
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Principal Investigators
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Sheila CO Martins, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Moinhos de Vento
Michael Brainin, MD
Role: STUDY_CHAIR
Danube University Krems, Austria
Valery Feigin, PhD
Role: STUDY_CHAIR
AUT University, Oakland, New Zealand
Thais L Secchi, MSc
Role: STUDY_DIRECTOR
Hospital Moinhos de Vento
Locations
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Unidade de Saúde Santa Cecília / Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Luiz A Nasi, PhD
Role: primary
Sheila Martins, PhD
Role: primary
References
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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.
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.
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.
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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.
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.
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.
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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.
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.
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.
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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.
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Related Links
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The HEARTS technical package provides a strategic approach to improving cardiovascular health in countries. It comprises six modules and an implementation guide
Other Identifiers
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41456820.6.1001.5330
Identifier Type: -
Identifier Source: org_study_id
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