NCT05285085

Brief Summary

A cross-sectional real-world data study designed to assess the use of statins in individuals assisted within the primary care system in Brazil.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,133,900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

May 14, 2024

Status Verified

March 1, 2022

Enrollment Period

26 days

First QC Date

March 2, 2022

Last Update Submit

May 10, 2024

Conditions

Cardiovascular DiseasesMyocardial InfarctionStrokeHypertensionDiabetes MellitusDyslipidemias

Keywords

cardiovascular diseasesprimary preventionsecondary preventionstatins

Outcome Measures

Primary Outcomes (2)

  • Statin use on secondary prevention

    Proportion of patients with previous myocardial infarction and/or stroke on statin use

    Baseline

  • Statin use on primary prevention

    Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use

    Baseline

Secondary Outcomes (13)

  • Statin use on patients with previous myocardial infarction

    Baseline

  • Statin use on patients with previous stroke

    Baseline

  • High dose statin use on secondary prevention

    Baseline

  • High dose statin use on patients with previous myocardial infarction

    Baseline

  • High dose statin use on patients with stroke

    Baseline

  • +8 more secondary outcomes

Study Arms (3)

Secondary prevention

Individuals with previous myocardial infarction and/or stroke

Drug: Statin

Primary prevention

Individuals with hypertension, diabetes and/or dyslipidemia

Drug: Statin

Unknown diagnosis

Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia

Drug: Statin

Interventions

StatinDRUG

Statin use

Also known as: simvastatin, calcium rosuvastatin, atorvastatin, pitavastatin, pravastatin, lovastatin, rosuvastatin
Primary preventionSecondary preventionUnknown diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals aged 18 years or older registered on the epHealth database will be used in this study.

You may qualify if:

  • All individuals aged 18 years or older registered on the epHealth database

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 04561-000, Brazil

Location

Related Publications (2)

  • Machline-Carrion MJ, Girotto AN, Nieri J, Pereira PM, Monfardini F, Forestiero F, Raupp P, Roveda F, Santo K, Berwanger O, Santos RD. Assessing statins use in a real-world primary care digital strategy: a cross-sectional analysis of a population-wide digital health approach. Lancet Reg Health Am. 2023 Jun 22;23:100534. doi: 10.1016/j.lana.2023.100534. eCollection 2023 Jul.

    PMID: 37497398RESULT

  • Santo K, Santos RD, Girotto AN, Nieri J, Monfardini F, Raupp P, Pereira PM, Berwanger O, Machline-Carrion MJ. Statins use for primary prevention of cardiovascular disease: A population-based digitally enabled real-world evidence cross-sectional study in primary care in Brazil. J Clin Lipidol. 2024 May-Jun;18(3):e384-e393. doi: 10.1016/j.jacl.2024.02.005. Epub 2024 Feb 20.

    PMID: 38431498RESULT

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionStrokeHypertensionDiabetes MellitusDyslipidemias

Interventions

Hydroxymethylglutaryl-CoA Reductase InhibitorsSimvastatinRosuvastatin CalciumAtorvastatinpitavastatinPravastatinLovastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic UsesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • M. Julia Machline-Carrion, PhD

    epHealth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 17, 2022

Study Start

November 19, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

May 14, 2024

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No plan

Locations

BR(1)