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Completed

NCT Number: NCT05285085

Real World Evidence Study of Statin Use 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.

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Key information

Conditions

Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Cerebrovascular Disorders Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Hypertension Infarction Ischemia Lipid Metabolism Disorders Metabolic Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Israelita Albert Einstein

São Paulo, 04561-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Statin

Drug

Statin use

Other names: simvastatin, calcium rosuvastatin, atorvastatin, pitavastatin, pravastatin, lovastatin, rosuvastatin

Primary outcomes

  1. Statin use on secondary prevention

    Time frame: Baseline

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

  2. Statin use on primary prevention

    Time frame: Baseline

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

Secondary outcomes

  1. Statin use on patients with previous myocardial infarction

    Time frame: Baseline

    Proportion of patients with previous myocardial infarction on statin use

  2. Statin use on patients with previous stroke

    Time frame: Baseline

    Proportion of patients with previous stroke on statin use

  3. 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

  4. High dose statin use on patients with previous myocardial infarction

    Time frame: Baseline

    Proportion of patients with previous myocardial infarction on high dose statin

  5. High dose statin use on patients with stroke

    Time frame: Baseline

    Proportion of patients with previous stroke on high dose statin

  6. Statin use on patients with diabetes

    Time frame: Baseline

    Proportion of patients with diabetes on statin use

  7. Statin use on patients with hypertension

    Time frame: Baseline

    Proportion of patients with hypertension on statin use

  8. Statin use on patients with dyslipidemia

    Time frame: Baseline

    Proportion of patients with dyslipidemia on statin use

  9. High dose statin use on patients with diabetes

    Time frame: Baseline

    Proportion of patients with diabetes on high dose statin

  10. High dose statin use on patients with hypertension

    Time frame: Baseline

    Proportion of patients with hypertension on high dose statin

  11. High dose statin use on patients with dyslipidemia

    Time frame: Baseline

    Proportion of patients with dyslipidemia on high dose statin

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Novartis
  • epHealth

Registry information

Official study title

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

Acronym: RWE-Statins

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2022
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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