Cardiovascular DiseasesRWE-StatinsNCT05285085
Real World Evidence Study of Statin Use in Brazil
An observational study of Cardiovascular Diseases and Myocardial Infarction, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Infarction, Stroke
- What is being tested?
- Statin
- How many people
- 2,133,900 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Nov 2021to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All individuals aged 18 years or older registered on the epHealth database will be used in this study.
Who may be able to join
- All individuals aged 18 years or older registered on the epHealth database
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 04561-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Stroke, Hypertension, Diabetes Mellitus, Dyslipidemias
- Being tested
- Statin
- Keywords
- cardiovascular diseases, primary prevention, secondary prevention, statins
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Stroke, Hypertension, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Also called simvastatin, calcium rosuvastatin, atorvastatin, pitavastatin
Statin use
| Study group | Role | What they receive |
|---|---|---|
| Secondary prevention | Individuals with previous myocardial infarction and/or stroke Receives: Drug: Statin | |
| Primary prevention | Individuals with hypertension, diabetes and/or dyslipidemia Receives: Drug: Statin | |
| Unknown diagnosis | Individuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statin use on secondary prevention
Proportion of patients with previous myocardial infarction and/or stroke on statin use
Measured: Baseline
Statin use on primary prevention
Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use
Measured: Baseline
Secondary outcomes (13)
Statin use on patients with previous myocardial infarction
Proportion of patients with previous myocardial infarction on statin use
Measured: Baseline
Statin use on patients with previous stroke
Proportion of patients with previous stroke on statin use
Measured: Baseline
High dose statin use on secondary prevention
Proportion of patients with previous myocardial infarction and/or stroke on high dose statin use
Measured: Baseline
High dose statin use on patients with previous myocardial infarction
Proportion of patients with previous myocardial infarction on high dose statin
Measured: Baseline
High dose statin use on patients with stroke
Proportion of patients with previous stroke on high dose statin
Measured: Baseline
Statin use on patients with diabetes
Proportion of patients with diabetes on statin use
Measured: Baseline
Statin use on patients with hypertension
Proportion of patients with hypertension on statin use
Measured: Baseline
Statin use on patients with dyslipidemia
Proportion of patients with dyslipidemia on statin use
Measured: Baseline
High dose statin use on patients with diabetes
Proportion of patients with diabetes on high dose statin
Measured: Baseline
High dose statin use on patients with hypertension
Proportion of patients with hypertension on high dose statin
Measured: Baseline
High dose statin use on patients with dyslipidemia
Proportion of patients with dyslipidemia on high dose statin
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start19 Nov 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,133,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- epHealth, Novartis
- Responsible party
- Sponsor
- Investigators
- M. Julia Machline-Carrion, PhD, Principal investigator, epHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285085
- Sponsor's protocol ID
- 53194121.0.0000.0071
- Acronym
- RWE-Statins
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
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.
PubMed 37497398Santo 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.
PubMed 38431498
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evidence Study for Assessing Statin Use for Primary and Secondary Prevention of Cardiovascular Disease in Primary Care in Brazil
- ClinicalTrials.gov ID
- NCT05285085
- Acronym / sponsor ID
- RWE-Statins / 53194121.0.0000.0071
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Stroke, Hypertension, Diabetes Mellitus, Dyslipidemias
- Keywords
- cardiovascular diseases, primary prevention, secondary prevention, statins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,133,900 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- epHealth, Novartis
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional real-world data study designed to assess the use of statins in individuals assisted within the primary care system in Brazil.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secondary prevention | – | Drug: StatinIndividuals with previous myocardial infarction and/or stroke |
| Primary prevention | – | Drug: StatinIndividuals with hypertension, diabetes and/or dyslipidemia |
| Unknown diagnosis | – | Drug: StatinIndividuals without a previous myocardial infarction and/or stroke or a diagnosis of hypertension, diabetes and/or dyslipidemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All individuals aged 18 years or older registered on the epHealth database will be used in this study.
Key inclusion criteria (1 listed)
- All individuals aged 18 years or older registered on the epHealth database
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StatinAlso: simvastatin, calcium rosuvastatin, atorvastatin, pitavastatinStatin use | Drug | Primary prevention, Secondary prevention, Unknown diagnosis |
Primary outcome
Statin use on secondary prevention
Time frame: Baseline
Proportion of patients with previous myocardial infarction and/or stroke on statin use
Statin use on primary prevention
Time frame: Baseline
Proportion of patients with hypertension, diabetes and/or dyslipidemia on statin use
13 secondary outcomes
Statin use on patients with previous myocardial infarction
Time frame: Baseline
Statin use on patients with previous stroke
Time frame: Baseline
High dose statin use on secondary prevention
Time frame: Baseline
High dose statin use on patients with previous myocardial infarction
Time frame: Baseline
High dose statin use on patients with stroke
Time frame: Baseline
Statin use on patients with diabetes
Time frame: Baseline
Statin use on patients with hypertension
Time frame: Baseline
Statin use on patients with dyslipidemia
Time frame: Baseline
High dose statin use on patients with diabetes
Time frame: Baseline
High dose statin use on patients with hypertension
Time frame: Baseline
High dose statin use on patients with dyslipidemia
Time frame: Baseline
Statin use on patients with unknown diagnosis
Time frame: Baseline
High dose statin use on patients with unknown diagnosis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Results publication: PubMed 37497398Machline-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.
- Results publication: PubMed 38431498Santo 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.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Julia Machline-Carrion, PhD principal investigator
epHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Myocardial Infarction, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statin use on secondary prevention (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.