Cluster Randomized Trial of a Digital Quality Improvement Intervention on LDLCholesterol Control
SAPPHIRE-LDL
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
2 other identifiers
interventional
1,465
1 country
28
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Jan 2023
Typical duration for not_applicable cardiovascular-diseases
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 21, 2022
CompletedStudy Start
First participant enrolled
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2025
CompletedApril 14, 2026
March 1, 2026
2.6 years
November 14, 2022
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1: LDL-C levels
LDL-C levels measured at a single visit
Baseline
Phase 2: LDL-C
LDL-C levels measured at the end of follow up of Phase 2
6 months
Secondary Outcomes (25)
Phase 1: Prescribed lipid-lowering therapy
Baseline
Phase 1: Prescribed combination lipid-lowering therapy
Baseline
Phase 1: Prescribed intensive lipid-lowering therapy
Baseline
Phase 1: Prescription of any statins
Baseline
Phase 1: Prescription of high intensity statins
Baseline
- +20 more secondary outcomes
Other Outcomes (8)
Phase 2: 5P-MACE (Major Cardiovascular Events)
6 months
Phase 2: 3P-MACE (Major Cardiovascular Events)
6 months
Phase 2: Cardiovascular death
6 months
- +5 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALReal-world evidence (RWE) platform to provide data on their clinical practice + usual care + Digitally-enabled Multifaceted Quality Improvement Intervention
Control group
ACTIVE COMPARATORRWE platform to provide data on their clinical practice + usual care
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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:
- 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
- Clusters that do not provide the unit/institution authorization form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Israelita Albert Einsteinlead
- epHealth primary care solutionscollaborator
- Novartiscollaborator
Study Sites (28)
Hospital da Bahia
Salvador, Estado de Bahia, Brazil
Hospital Santa Lúcia
Poços de Caldas, Minas Gerais, Brazil
Hospital e Maternidade Angelina Caron
Campina Grande do Sul, Paraná, Brazil
Hospital Regional Hans Dieter Schmidt
Joinville, Santa Catarina, Brazil
Centro de Pesquisa Clínica do Coração
Aracaju, Sergipe, Brazil
Hospital Universitário São Francisco de Assis
Bragança Paulista, São Paulo, Brazil
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, Brazil
Irmandade da Santa Casa de Misericórdia de Marilia
Marília, São Paulo, Brazil
Hospital Carlos Fernando Malzoni
Matão, São Paulo, Brazil
Hospital Universitário João de Barros Barreto
Belém, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu
Botucatu, Brazil
Santa Casa de Curitiba
Curitiba, Brazil
Centro de Pesquisas em Diabetes e Doenças Endócrino-metabólicas
Fortaleza, Brazil
Hospital Municipal de Aparecida de Goiânia
Goiânia, Brazil
Hospital Ruy Azeredo
Goiânia, Brazil
Centro de Pesquisas Clínicas Dr Marco Mota
Maceió, Brazil
Instituto Atena de Pesquisa Clínica
Natal, Brazil
Unidade Hospital Municipal Antônio Giglio
Osasco, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Santa Casa de Porto Alegre
Porto Alegre, Brazil
Hospital Regional Presidente Prudente
Presidente Prudente, Brazil
Clínica Silvestre Santé
Rio Branco, Brazil
Instituto Nacional de Cardiologia
Rio de Janeiro, Brazil
Instituto de Cardiologia de Santa Catarina
São José, Brazil
Hospital São Paulo (UNIFESP)
São Paulo, Brazil
Hospital São Paulo Universidade Federal de São Paulo
São Paulo, Brazil
Instituto de Cardiologia Dante Pazzanese
São Paulo, Brazil
Hospital Evangélico de Vila Velha
Vila Velha, Brazil
Related Publications (1)
Machline-Carrion MJ, Girotto AN, Raupp P, Marton Pereira P, Monfardini F, Santos RD, Santo K, Ray K, Cannon CP, Berwanger O. 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.
PMID: 39909341BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M. Julia Machline-Carrion, PhD
epHealth
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2022
First Posted
November 21, 2022
Study Start
January 10, 2023
Primary Completion
August 15, 2025
Study Completion
December 17, 2025
Last Updated
April 14, 2026
Record last verified: 2026-03