Real World Evidence Study of Statin Use in Brazil (RWE-Statins)

May 10, 2024 updated by: Hospital Israelita Albert Einstein

Real World Evidence Study for Assessing Statin Use for Primary and Secondary Prevention of Cardiovascular Disease in Primary Care in Brazil

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Considering the high cardiovascular risk associated to high cholesterol levels, assessing the use of statins in secondary prevention as well as primary prevention individuals in real world settings is key to enable public health policy improvements.

The aim of the present study is to assess statins use in primary and secondary prevention individuals assisted by community care workers in the primary care system in Brazil, using a free real world data collection tool (epHealth database). Evaluating factors associated with statins use as well as high dose statins use are also objectives of the study.

Study Type

Observational

Enrollment (Actual)

2133900

Contacts and Locations

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

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04561-000
        • Hospital Israelita Albert Einstein

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Secondary prevention
Individuals with previous myocardial infarction and/or stroke
Drug: Statin
Statin use
Other Names:
  • atorvastatin
  • rosuvastatin
  • simvastatin
  • lovastatin
  • pravastatin
  • pitavastatin
  • calcium rosuvastatin
Primary prevention
Individuals with hypertension, diabetes and/or dyslipidemia
Drug: Statin
Statin use
Other Names:
  • atorvastatin
  • rosuvastatin
  • simvastatin
  • lovastatin
  • pravastatin
  • pitavastatin
  • calcium rosuvastatin
Unknown diagnosis
Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia
Drug: Statin
Statin use
Other Names:
  • atorvastatin
  • rosuvastatin
  • simvastatin
  • lovastatin
  • pravastatin
  • pitavastatin
  • calcium rosuvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statin use on secondary prevention
Time Frame: Baseline
Proportion of patients with previous myocardial infarction and/or stroke on statin use
Baseline
Statin use on primary prevention
Time Frame: Baseline
Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statin use on patients with previous myocardial infarction
Time Frame: Baseline
Proportion of patients with previous myocardial infarction on statin use
Baseline
Statin use on patients with previous stroke
Time Frame: Baseline
Proportion of patients with previous stroke on statin use
Baseline
High dose statin use on secondary prevention
Time Frame: Baseline
Proportion of patients with previous myocardial infarction and/or stroke on high dose statin use
Baseline
High dose statin use on patients with previous myocardial infarction
Time Frame: Baseline
Proportion of patients with previous myocardial infarction on high dose statin
Baseline
High dose statin use on patients with stroke
Time Frame: Baseline
Proportion of patients with previous stroke on high dose statin
Baseline
Statin use on patients with diabetes
Time Frame: Baseline
Proportion of patients with diabetes on statin use
Baseline
Statin use on patients with hypertension
Time Frame: Baseline
Proportion of patients with hypertension on statin use
Baseline
Statin use on patients with dyslipidemia
Time Frame: Baseline
Proportion of patients with dyslipidemia on statin use
Baseline
High dose statin use on patients with diabetes
Time Frame: Baseline
Proportion of patients with diabetes on high dose statin
Baseline
High dose statin use on patients with hypertension
Time Frame: Baseline
Proportion of patients with hypertension on high dose statin
Baseline
High dose statin use on patients with dyslipidemia
Time Frame: Baseline
Proportion of patients with dyslipidemia on high dose statin
Baseline
Statin use on patients with unknown diagnosis
Time Frame: Baseline
Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on statin use
Baseline
High dose statin use on patients with unknown diagnosis
Time Frame: Baseline
Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on high dose statin use
Baseline

Collaborators and Investigators

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

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Novartis
epHealth

Investigators

  • Principal Investigator: M. Julia Machline-Carrion, PhD, epHealth

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

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)

November 19, 2021

Primary Completion (Actual)

December 15, 2021

Study Completion (Actual)

December 15, 2021

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53194121.0.0000.0071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan

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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