Real World Evidence Study of Statin Use in Brazil

Stroke Clinical Trial

— RWE-Statins  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285085
• Other study ID #: 53194121.0.0000.0071
• Status: Completed
• Start date: November 19, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: March 2022
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2133900
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Dyslipidemias
• Hypertension
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Drug:
• Statin
Statin use

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	epHealth, Novartis

Country where clinical trial is conducted

Brazil, 

References & 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 digi — View Citation

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 p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Statin use on secondary prevention	Proportion of patients with previous myocardial infarction and/or stroke on statin use	Baseline
Primary	Statin use on primary prevention	Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use	Baseline
Secondary	Statin use on patients with previous myocardial infarction	Proportion of patients with previous myocardial infarction on statin use	Baseline
Secondary	Statin use on patients with previous stroke	Proportion of patients with previous stroke on statin use	Baseline
Secondary	High dose statin use on secondary prevention	Proportion of patients with previous myocardial infarction and/or stroke on high dose statin use	Baseline
Secondary	High dose statin use on patients with previous myocardial infarction	Proportion of patients with previous myocardial infarction on high dose statin	Baseline
Secondary	High dose statin use on patients with stroke	Proportion of patients with previous stroke on high dose statin	Baseline
Secondary	Statin use on patients with diabetes	Proportion of patients with diabetes on statin use	Baseline
Secondary	Statin use on patients with hypertension	Proportion of patients with hypertension on statin use	Baseline
Secondary	Statin use on patients with dyslipidemia	Proportion of patients with dyslipidemia on statin use	Baseline
Secondary	High dose statin use on patients with diabetes	Proportion of patients with diabetes on high dose statin	Baseline
Secondary	High dose statin use on patients with hypertension	Proportion of patients with hypertension on high dose statin	Baseline
Secondary	High dose statin use on patients with dyslipidemia	Proportion of patients with dyslipidemia on high dose statin	Baseline
Secondary	Statin use on patients with unknown diagnosis	Proportion of patients without previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia on statin use	Baseline
Secondary	High dose statin use on patients with unknown diagnosis	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