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Cardiovascular DiseasesSAPPHIRE-LDLNCT05622929

Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control

A study testing Digitally-enabled Multifaceted Quality Improvement Intervention in people with Cardiovascular Diseases and Atherosclerosis, run by Hospital Israelita Albert Einstein at 28 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Digitally-enabled Multifaceted Quality Improvement Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,465 participants
Where
28 sitesBrazil
Study dates
10 Jan 2023to 17 Dec 2025
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of using a smartphone with iOS or Android System AND
  • Established ASCVD, including:
  • Coronary Artery Disease (CAD):
  • Prior myocardial infarction
  • Prior coronary revascularization - percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
  • Angiographic or computerized tomography (CT)-imaging evidence of coronary atherosclerosis (≥ 50% stenosis in at least one major epicardial coronary artery)
Show all 17Show fewer
  • Stroke:
  • Prior ischemic stroke thought not to be caused by an embolic cause (e.g., atrial fibrillation, valvular heart disease or mural thrombus)
  • Peripheral Artery Disease (PAD):
  • Prior documentation of a resting ankle-brachial index ≤ 0.9
  • History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery
  • Prior non-traumatic amputation of a lower extremity due to peripheral artery disease
  • History of prior percutaneous or surgical carotid artery revascularization
  • Carotid Stenosis > 50% on prior angiography or ultrasound AND
  • Provision of informed consent
  • Outpatient Clinics from public or private hospitals OR, Private Practices, which assist patients with previous ASCVD on secondary prevention that provide a unit/institution authorization form for participation in the trial AND
  • Minimum monthly volume of 20 ASCVD patients

Who cannot join

  • Patients with a recent cardiovascular event, less than 3 months prior to study inclusion
  • Patients with LDL-C ≤ 50 mg/dL
  • Current participation in other clinical trials involving lipid lowering treatments
  • Patients that do not consent to trial participation
  • Cluster Eligibility Criteria:
  • Clusters that do not provide the unit/institution authorization form.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Brazil28 sites

  • Centro de Pesquisa Clínica do Coração

    Aracaju, Sergipe

  • Hospital Universitário João de Barros Barreto

    Belém

  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu

    Botucatu

  • Hospital Universitário São Francisco de Assis

    Bragança Paulista, São Paulo

  • Hospital e Maternidade Angelina Caron

    Campina Grande do Sul, Paraná

  • Instituto de Pesquisa Clínica de Campinas

    Campinas, São Paulo

  • Santa Casa de Curitiba

    Curitiba

  • Centro de Pesquisas em Diabetes e Doenças Endócrino-metabólicas

    Fortaleza

  • Hospital Municipal de Aparecida de Goiânia

    Goiânia

  • Hospital Ruy Azeredo

    Goiânia

  • Hospital Regional Hans Dieter Schmidt

    Joinville, Santa Catarina

  • Centro de Pesquisas Clínicas Dr Marco Mota

    Maceió

  • Irmandade da Santa Casa de Misericórdia de Marilia

    Marília, São Paulo

  • Hospital Carlos Fernando Malzoni

    Matão, São Paulo

  • Instituto Atena de Pesquisa Clínica

    Natal

  • Unidade Hospital Municipal Antônio Giglio

    Osasco

  • Hospital Santa Lúcia

    Poços de Caldas, Minas Gerais

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre

  • Santa Casa de Porto Alegre

    Porto Alegre

  • Hospital Regional Presidente Prudente

    Presidente Prudente

  • Clínica Silvestre Santé

    Rio Branco

  • Instituto Nacional de Cardiologia

    Rio de Janeiro

  • Hospital da Bahia

    Salvador, Estado de Bahia

  • Instituto de Cardiologia de Santa Catarina

    São José

  • Hospital São Paulo (UNIFESP)

    São Paulo

  • Hospital São Paulo Universidade Federal de São Paulo

    São Paulo

  • Instituto de Cardiologia Dante Pazzanese

    São Paulo

  • Hospital Evangélico de Vila Velha

    Vila Velha

Other trials in Brazil

About this study

Official title: A Pragmatic Cluster Randomized Trial to Assess the Effect of a Digitally Enabled Quality Improvement Intervention on LDL Cholesterol Control in Atherosclerotic Established Cardiovascular Disease Patients

Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in atherosclerotic established cardiovascular disease (ASCVD) patients.

Read the detailed description

Elevation in low density lipoprotein (LDL) cholesterol (LDL-C) is a causal risk factor for atherosclerotic established cardiovascular disease (ASCVD). Reduction of LDL-C with statins has been clearly demonstrated as a robust and cost-effective way of reducing the burden of ASCVD in individuals at risk. ASCVD is the leading cause of death and disability in Brazil and therefore prevention guidelines recommend LDL-C reduction with the aim of reducing disease burden in individuals at risk. Studies have shown a clear hiatus on awareness and treatment of cholesterol in Brazil. Thus, it became imperative to develop knowledge translation projects aiming at bridging the gap between science and clinical practice and ultimately leading to better outcomes. Cluster randomized clinical trials are the highest quality type of clinical research to test educational and active interventions aimed at changing behaviors or clinical practices.To our knowledge, data from this study will be crucial to leverage LDL-C treatment in Brazil, considering efforts to improve population health. The present study represents one of the first trials testing a quality improvement (QI) intervention targeted to LDL-C reduction in ASCVD patients conducted in a middle-income country. These results will address whether the proposed QI intervention is feasible and effective in these settings. Therefore, this study is a pragmatic cluster randomized trial to assess the effect of a digitally enabled QI intervention on LDL-C control in ASCVD patients. This study will have 2 phases. Phase 1 will be an observational phase prior to randomization of clusters with the objective to assess the baseline LDL-C levels achieved for target patients. Phase 2 will be an interventional phase, in which clusters will be randomized to the digitally enabled quality improvement intervention or usual care, with the objective to assess the effect of a digitally enabled QI intervention on control of LDL-C levels in ASCVD patients.

Being tested
Digitally-enabled Multifaceted Quality Improvement Intervention, Usual care
Keywords
Cardiovascular diseases, Atherosclerosis, Dyslipidemias
Medical subject headings
Cardiovascular Diseases, Atherosclerosis, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digitally-enabled Multifaceted Quality Improvement InterventionBehavioural

    Digitally-enabled multifaceted strategy in addition to access to a RWE platform to provide clinical data. The digitally-enabled multifaceted strategy will include various tools that will provide support to the health professionals responsible for treating ASCVD patients in each center as well as patients, including:

    • Knowledge of effective lipid lowering therapies
    • Clinical decision support
    • Audit and feedback on adherence to optimal clinical management
    • Audit and feedback on LDL-C control

  • Usual careBehavioural

    Health professionals responsible for treating ASCVD patients in each center will continue to provide usual care to ASCVD patients in addition to provide data through a RWE platform.

Study groups in NCT05622929
Study groupRoleWhat they receive
Intervention groupExperimentalReal-world evidence (RWE) platform to provide data on their clinical practice + usual care + Digitally-enabled Multifaceted Quality Improvement Intervention
Receives: Behavioral: Digitally-enabled Multifaceted Quality Improvement Intervention
Control groupActive comparatorRWE platform to provide data on their clinical practice + usual care
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: LDL-C levels

    LDL-C levels measured at a single visit

    Measured: Baseline

  2. Phase 2: LDL-C

    LDL-C levels measured at the end of follow up of Phase 2

    Measured: 6 months

Secondary outcomes (25)

  1. Phase 1: Prescribed lipid-lowering therapy

    Percentage of patients on prescribed lipid-lowering therapy

    Measured: Baseline

  2. Phase 1: Prescribed combination lipid-lowering therapy

    Percentage of patients on prescribed combination lipid-lowering therapy

    Measured: Baseline

  3. Phase 1: Prescribed intensive lipid-lowering therapy

    Percentage of patients on prescribed intensive lipid-lowering therapy

    Measured: Baseline

  4. Phase 1: Prescription of any statins

    Percentage of prescription of any statins

    Measured: Baseline

  5. Phase 1: Prescription of high intensity statins

    Percentage of prescription of high intensity statins

    Measured: Baseline

  6. Phase 1: Prescription of ezetimibe

    Percentage of prescription of ezetimibe

    Measured: Baseline

  7. Phase 1: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors

    Percentage of prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors

    Measured: Baseline

  8. Phase 1: LDL-C < 50 mg/dL

    Percentage of patients with LDL-C < 50 mg/dL

    Measured: Baseline

  9. Phase 2: Prescribed lipid-lowering therapy

    Percentage of patients on prescribed lipid-lowering therapy

    Measured: 6 months

  10. Phase 2: Prescribed combination lipid-lowering therapy

    Percentage of patients on prescribed combination lipid-lowering therapy

    Measured: 6 months

  11. Phase 2: Prescribed intensive lipid-lowering therapy

    Percentage of patients on prescribed intensive lipid-lowering therapy

    Measured: 6 months

  12. Phase 2: Prescription of any statins

    Percentage of prescription of any statins

    Measured: 6 months

  13. Phase 2: Prescription of high intensity statins

    Percentage of prescription of high intensity statins

    Measured: 6 months

  14. Phase 2: Prescription of moderate intensity statins

    Percentage of prescription of moderate intensity statins

    Measured: 6 months

  15. Phase 2: Prescription of low intensity statins

    Percentage of prescription of low intensity statins

    Measured: 6 months

  16. Phase 2: Prescription of ezetimibe

    Percentage of prescription of ezetimibe

    Measured: 6 months

  17. Phase 2: Prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors

    Percentage of prescription of PCSK9 monoclonal antibody or siRNA PCSK9 inhibitors

    Measured: 6 months

  18. Phase 2: LDL-C < 50 mg/dL

    Percentage of patients with LDL-C < 50 mg/dL

    Measured: 6 months

  19. Phase 2: LDL-C relative change

    Change in LDL-C relative to baseline

    Measured: 6 months

  20. Phase 2: LDL-C reduction of ≥50%

    Percentage of patients with LDL-C reduction of ≥50% relative to baseline

    Measured: 6 months

  21. Phase 2: non-HDL-C relative change

    Change in non-HDL-C relative to baseline

    Measured: 6 months

  22. Phase 2: Barriers for drug prescription

    Barriers for drug prescription at the system (cluster) and physician level

    Measured: 6 months

  23. Phase 2: Adherence to prescribed lipid-lowering therapy

    Patient´s adherence to prescribed lipid-lowering therapy

    Measured: 6 months

  24. Phase 2: Barriers for drug adherence

    Patient´s barriers for drug adherence

    Measured: 6 months

  25. Phase 2: Intolerance to Statins

    Percentage of patients with intolerance to Statins

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start10 Jan 2023
  3. Primary completion15 Aug 2025
  4. Study completion17 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized clinical trial
Masking
None (open label)
Enrolment
1,465 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622929
Sponsor's protocol ID
CKJX839A1BR05R
Other IDs
63520022.6.1001.0071
Acronym
SAPPHIRE-LDL
Status last verified
Mar 2026
First submitted
14 Nov 2022
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Machline-Carrion MJ, Girotto AN, Raupp P, Marton Pereira P, Monfardini F, Santos RD, Santo K, Ray K, Cannon CP, Berwanger O; SAPPHIRE-LDL Trial. Rationale, design and prerandomization data for a cluster randomized trial to assess the effect of a digitally enabled quality improvement intervention on LDL-C control in established atherosclerotic cardiovascular disease patients: The SAPPHIRE-LDL trial. Am Heart J. 2025 Jun;284:1-10. doi: 10.1016/j.ahj.2025.01.019. Epub 2025 Feb 3.

    PubMed 39909341

  • Machline-Carrion MJ, Santo K, Girotto AN, Raupp P, Pereira PM, Monfardini F, Nakagawa Santos RH, Pereira M, Dos Santos Sampaio B, Moia D, de Oliveira Farias G, Dall'Orto FTC, Pavanello R, Polanczyk CA, Silvestre OM, Assad MHV, de Oliveira Paiva MSM, Dos Santos MON, Okoshi MP, Bosso CEDCN, de Azeredo Bastos LA, de Moura Joaquim R, Arruda JA, Araujo GF, Riquena B, Rezende V, Alvarenga L, Ray K, Cannon CP, Santos RD, Berwanger O; SAPPHIRE-LDL Investigators. Digitally Enabled Quality Improvement Intervention and LDL-C Control in Atherosclerotic Cardiovascular Disease: The SAPPHIRE-LDL Cluster Randomized Clinical Trial. JAMA Cardiol. 2026 Jul 22:e262510. doi: 10.1001/jamacardio.2026.2510. Online ahead of print.

    PubMed 42485013

Questions about this trial

What is this clinical trial studying?

A study testing Digitally-enabled Multifaceted Quality Improvement Intervention in people with Cardiovascular Diseases and Atherosclerosis, run by Hospital Israelita Albert Einstein at 28 sites 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 17 inclusion and 6 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 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites 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?

Phase 1: LDL-C levels (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 NCT05622929, 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 Apr 2026.

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