An observational study in Dyslipidemias, Hypercholesterolemia and Cardiovascular Diseases, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Observational
Among 26 studies in Hypercholesterolemia with a site in Mexico — 1 open to participants now, 6 under way, 4 of them phase 3. Hypercholesterolemia · Mexico.
Among the 26 studies in Hypercholesterolemia with a site in Mexico, this one is the only one that started in 2027, is one of 2 observational ones, and was the 26th registered.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
Browse Hypercholesterolemia studies →1 of the 26 studies in Hypercholesterolemia with a site in Mexico is open now.
A study can be open while its sites in Mexico have not opened yet or have stopped. Only those recruiting at a site in Mexico →
Of the 55 Hypercholesterolemia studies recruiting now, 23 (42%) set no upper age limit and 20 (36%) stop at 75 or younger; 9 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,600 is above the median of 1,000 across 144 observational studies indexed under Hypercholesterolemia.
Median enrollment 978 across the 24 interventional studies, 934 across the 2 observational. Of the 20 that completed or were terminated, 17 (85%) have results posted.
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24 of 26 have an industry lead sponsor. The 10 most frequent:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran has 2 studies filed under Hypercholesterolemia — fewer than ten, so there is no comparison to draw.
1 of the studies in Hypercholesterolemia with a site in Mexico that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05030428Phase 3Novartis PharmaceuticalsStudy of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease | 2027-05-10 |
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Among the 26 studies in Hypercholesterolemia with a site in Mexico, from their registry updates:
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SANTORINI-MX is a nationwide, multicenter, prospective, observational study designed to evaluate cholesterol management among adults in Mexico who are at high or very high risk of cardiovascular disease.
The main objective is to determine the proportion of patients who achieve the recommended low-density lipoprotein cholesterol (LDL-C) goals according to the 2019 European Society of Cardiology/European Atherosclerosis Society guidelines.
Approximately 1,600 adults will be enrolled from an initial network of 15 public and private healthcare centers across Mexico. Participants will be evaluated at enrollment and followed for approximately 12 months, with an allowable follow-up window of 10 to 14 months.
The study will collect information on cholesterol levels, cardiovascular risk factors, lipid-lowering medications, treatment changes, medication adherence, and barriers to optimal cholesterol management. Researchers will also examine whether treatment is intensified when LDL-C goals are not achieved.
This is a non-interventional study. Medical treatments and decisions will remain under the responsibility of each participant's treating physician, and no additional medical procedures will be required solely for research purposes.
The findings are expected to help identify gaps in cholesterol management in Mexico and inform future strategies to improve cardiovascular prevention and patient care.
Background and Rationale
Atherosclerotic cardiovascular disease (ASCVD) remains a major cause of morbidity and mortality in Mexico. Lowering low-density lipoprotein cholesterol (LDL-C) is a fundamental strategy for reducing cardiovascular risk. Despite the availability of effective lipid-lowering therapies, substantial gaps persist between guideline-recommended LDL-C targets and lipid management in routine clinical practice.
International observational studies, including DA VINCI and SANTORINI, have documented limited achievement of LDL-C goals and underutilization of combination lipid-lowering therapies. However, contemporary standardized data describing lipid management practices, treatment intensification, and barriers to optimal lipid control remain limited in Mexico.
SANTORINI-MX aims to address these knowledge gaps by establishing a nationwide observational registry of adults at high and very high cardiovascular risk.
Study Design and Population
SANTORINI-MX is a multicenter, prospective, observational, non-interventional patient registry coordinated by the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), with academic support from the Sociedad Mexicana de Nutrición y Endocrinología (SMNE).
Approximately 1,600 participants will be consecutively enrolled from an initial network of 15 public and private healthcare centers across Mexico.
Eligible participants will be adults aged 18 years or older classified as having high or very high cardiovascular risk according to the 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) clinical risk categories. Participants must have an indication for lipid-lowering therapy or be receiving such treatment, have an available baseline LDL-C measurement, have an expected survival exceeding one year, and provide written informed consent.
The study will include both previously treated individuals and patients newly diagnosed or initiating lipid-lowering treatment.
Lipid Assessment and Treatment Goals
The primary objective is to estimate the proportion of participants achieving risk-based LDL-C targets according to the 2019 ESC/EAS guidelines:
An exploratory LDL-C target below 40 mg/dL will also be evaluated in participants with recurrent cardiovascular events within two years, when sufficient information is available.
Baseline lipid measurements obtained within the 12 months preceding enrollment will be accepted. Follow-up LDL-C measurements will be assessed at 12 ± 2 months, using the measurement closest to the target follow-up date when multiple results are available.
Lipid parameters will be standardized through centralized calculations, including LDL-C using the Sampson equation, non-HDL cholesterol, and remnant cholesterol.
Clinical and Therapeutic Data Collection
Data will be obtained from routine medical records and brief patient interviews. Information will include demographic characteristics, cardiovascular history, comorbidities, laboratory findings, lipid-lowering medication use, treatment intensity, medication adherence, statin intolerance, and barriers to treatment optimization.
Lipid-lowering therapies of interest include statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, bempedoic acid, fibrates, and omega-3 fatty acids.
The study will evaluate treatment modifications during follow-up, including statin dose escalation, switching to more potent agents, combination therapy, and initiation of advanced lipid-lowering therapies.
Clinical inertia will be operationally defined as LDL-C above the recommended risk-based target without treatment intensification during follow-up. Reasons for the absence of intensification will be documented when available.
Barriers to treatment optimization will be classified at the patient, physician, and institutional levels, including medication cost, adherence difficulties, treatment availability, administrative requirements, and clinical decision-making.
Additional laboratory parameters, including apolipoprotein B, lipoprotein(a), glycated hemoglobin, kidney function markers, and inflammatory biomarkers, will be assessed when available in routine care.
Patient-reported outcomes, including health-related quality of life using EQ-5D-5L and patient activation using PAM-13, will be assessed when feasible. Cardiovascular events and healthcare resource utilization will be recorded as exploratory outcomes.
Follow-up and Data Management
Participants will undergo baseline assessment and follow-up at 12 ± 2 months. Follow-up information will be obtained through routine medical records and, when necessary and authorized by participants, direct telephone contact.
No additional medical procedures or protocol-assigned treatments will be required. All clinical decisions will remain at the discretion of the treating physicians.
Study data will be entered into a centralized, institutionally hosted REDCap database. Standardized electronic case report forms, automated validation rules, investigator training, and centralized data quality monitoring will be implemented.
Statistical Analysis
The primary analysis will estimate the proportion of participants achieving LDL-C targets, with corresponding 95% confidence intervals.
Descriptive analyses will summarize clinical characteristics, lipid profiles, treatment patterns, and goal attainment. Continuous variables will be reported using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages.
Prespecified subgroup analyses will consider cardiovascular risk category, established ASCVD, diabetes mellitus, chronic kidney disease, menopausal status, healthcare sector, and treating physician specialty.
Exploratory multivariable models will assess factors associated with failure to achieve LDL-C targets and clinical inertia. Missing data will be reported transparently, and sensitivity analyses will be performed when appropriate.
Expected Contribution
SANTORINI-MX will provide contemporary evidence on lipid management gaps among Mexican patients at high and very high cardiovascular risk. Its findings are intended to support improved clinical practice, professional education, and future implementation strategies aimed at optimizing cardiovascular prevention.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 1,000 across 144 observational studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Compared within Hypercholesterolemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dyslipidemias. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population will consist of adults aged 18 years or older classified as having high or very high cardiovascular risk according to the 2019 ESC/EAS clinical risk categories. Eligible participants will be receiving or have a clinical indication for lipid-lowering therapy and will be recruited consecutively from an initial network of approximately 15 public and private healthcare centers across Mexico. Participants may have established atherosclerotic cardiovascular disease, diabetes mellitus, chronic kidney disease, familial hypercholesterolemia, or other clinical conditions associated with elevated cardiovascular risk. Both previously treated and newly treated patients will be eligible.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults aged 18 years or older classified as having high or very high cardiovascular risk according to the 2019 ESC/EAS guidelines, who are receiving or have a clinical indication for lipid-lowering therapy. Participants will be consecutively enrolled at participating healthcare centers in Mexico and assessed at baseline and after 12 ± 2 months. Lipid levels, cardiovascular risk factors, lipid-lowering treatments, treatment intensification, medication adherence, and barriers to optimal lipid management will be recorded. All treatments will be prescribed according to routine clinical practice, without protocol-assigned interventions.
Drug: Lipid-Lowering Therapy in Routine Clinical Practice
Lipid-lowering medications prescribed as part of routine clinical care, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, bempedoic acid, fibrates, and omega-3 fatty acids. Medication class, dose, treatment intensity, combinations, and changes during follow-up will be documented. Treatment decisions will be made exclusively by the treating physicians. No medication will be assigned, administered, or modified by the study protocol.
Proportion of Participants Achieving Risk-Based LDL-C Treatment Goals
The percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) targets according to their cardiovascular risk category, as defined by the 2019 ESC/EAS guidelines: LDL-C below 70 mg/dL for high-risk participants and below 55 mg/dL for very-high-risk participants. The numerator will be the number of participants achieving their corresponding risk-based LDL-C target, and the denominator will be the number of evaluable participants with baseline LDL-C data. Results will be reported overall and stratified by cardiovascular risk category, with 95% confidence intervals.
Time frame: Baseline (at enrollment; LDL-C measurement obtained within the preceding 12 months)
Proportion of Participants Achieving Risk-Based LDL-C Goals at 12 Months
Percentage of participants achieving their cardiovascular risk-based LDL-C goals at follow-up, defined according to the 2019 ESC/EAS guidelines as LDL-C below 70 mg/dL for high-risk patients and below 55 mg/dL for very-high-risk patients. The numerator will include participants achieving their respective LDL-C target, and the denominator will include participants with an evaluable follow-up LDL-C measurement. Results will be reported overall and stratified by cardiovascular risk category, with 95% confidence intervals.
Time frame: 12 months after enrollment (±2 months)
Lipid-Lowering Treatment Patterns at Baseline and Follow-up
Number and percentage of participants receiving each lipid-lowering therapy class, including statins, ezetimibe, PCSK9 inhibitors, inclisiran, bempedoic acid, fibrates, and omega-3 fatty acids. Statin intensity (low, moderate, or high) and use of combination therapies will be described at baseline and follow-up.
Time frame: Baseline and 12 months (±2 months)
Proportion of Participants With Lipid-Lowering Treatment Intensification
Percentage of participants undergoing lipid-lowering treatment intensification during follow-up, defined as an increase in statin intensity, addition of another lipid-lowering agent, initiation of advanced lipid-lowering therapy, or escalation to combination treatment. Types and reasons for intensification will be described.
Time frame: From enrollment to 12 months (±2 months)
Proportion of Participants With Clinical Inertia in Lipid-Lowering Treatment
Clinical inertia will be assessed as a single binary outcome (yes/no) among participants with LDL-C levels above their cardiovascular risk-based treatment targets according to the 2019 ESC/EAS guidelines. It will be defined as the absence of lipid-lowering treatment intensification during follow-up. Treatment intensification includes an increase in statin intensity, initiation of ezetimibe, or initiation of advanced lipid-lowering therapy. These criteria will be combined to classify each participant as having or not having clinical inertia, rather than being reported separately. The outcome will be expressed as the percentage of evaluable participants with LDL-C above their treatment targets who do not undergo treatment intensification. The numerator will include participants with clinical inertia, and the denominator will include all evaluable participants with LDL-C above their corresponding targets.
Time frame: From enrollment through 12 months (±2 months)
Changes in Lipid Parameters From Baseline to 12 Months
Absolute changes from baseline to follow-up in low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), remnant cholesterol, and triglycerides, expressed in mg/dL. Apolipoprotein B (mg/dL) and lipoprotein(a) (mg/dL or nmol/L) will also be evaluated when available. LDL-C and remnant cholesterol will be calculated centrally using standardized methods, including the Sampson equation for LDL-C. Changes will be summarized overall and by cardiovascular risk category.
Time frame: Baseline and 12 months after enrollment (±2 months)
Proportion of Participants With Barriers to Lipid-Lowering Treatment Optimization
Percentage of participants with at least one documented barrier to lipid-lowering treatment optimization, assessed through patient interviews and/or treating physician evaluation. Barriers will be classified as patient-related (medication cost, fear of adverse effects, forgetfulness, polypharmacy, and access difficulties), physician-related (perceived lack of need for treatment intensification, uncertainty regarding treatment targets, and limited consultation time), or institutional (medication unavailability, drug shortages, and administrative requirements). The numerator will include participants with at least one reported barrier, and the denominator will include participants with an evaluable barrier assessment. Individual barrier categories will be summarized descriptively.
Time frame: Baseline and 12 months after enrollment (±2 months)
Proportion of Participants With High Medication Adherence
Percentage of participants classified as having high adherence to prescribed lipid-lowering therapy, based on patient self-report and treating physician assessment. Adherence will be categorized as high, moderate, or low according to medication-taking behavior, missed doses, treatment discontinuation, and understanding of treatment instructions. The denominator will include participants with an evaluable adherence assessment.
Time frame: Baseline and 12 months after enrollment (±2 months)
Proportion of Participants With Documented Statin Intolerance
Statin intolerance will be evaluated as a single binary outcome (yes/no) using the study questionnaire and available clinical information. The assessment will consider previous exposure to at least two different statins, muscle-related symptoms or creatine kinase elevation, and available evidence of symptom improvement following statin discontinuation or recurrence after rechallenge. These clinical and laboratory findings will be used collectively to determine whether each participant meets the study definition of documented statin intolerance; they will not be reported as separate outcome measures under this endpoint. The outcome will be expressed as the percentage of evaluable participants classified as having documented statin intolerance. The numerator will be the number of participants meeting the study definition of statin intolerance, and the denominator will be the total number of participants with an evaluable statin intolerance assessment.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Absolute change in glycated hemoglobin (HbA1c), expressed in percentage points, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired HbA1c measurements. This is a continuous laboratory measurement, not a scoring scale.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in High-Sensitivity C-Reactive Protein From Baseline to 12 Months
Absolute change in high-sensitivity C-reactive protein (hs-CRP), expressed in mg/L, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired hs-CRP measurements. This is a continuous laboratory measurement, not a scoring scale.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in Serum Creatinine From Baseline to 12 Months
Absolute change in serum creatinine concentration, expressed in mg/dL, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired serum creatinine measurements. This is a continuous laboratory measurement, not a scoring scale.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Change in health-related quality of life assessed using the EQ-5D-5L questionnaire, including five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels, from no problems to extreme problems or inability to perform the activity. Responses will be analyzed at baseline and follow-up when questionnaires are available.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in Patient Activation Measure (PAM-13) Score
Change in patient activation from baseline to follow-up, assessed using the 13-item Patient Activation Measure (PAM-13). The instrument evaluates patients' knowledge, skills, and confidence in managing their health. Standardized activation scores range from 0 to 100, with higher scores indicating greater patient activation. Changes will be analyzed among participants with evaluable questionnaires at both time points.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in Estimated Glomerular Filtration Rate From Baseline to 12 Months
Absolute change in estimated glomerular filtration rate (eGFR), expressed in mL/min/1.73 m², from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired eGFR measurements. This is a continuous renal function measurement, not a scoring scale.
Time frame: Baseline and 12 months after enrollment (±2 months)
Change in Urinary Albumin-to-Creatinine Ratio From Baseline to 12 Months
Absolute change in urinary albumin-to-creatinine ratio (UACR), expressed in mg/g, from baseline to 12 months. The change will be calculated as the 12-month value minus the baseline value. Analyses will include participants with available paired UACR measurements. This is a continuous laboratory measurement, not a scoring scale.
Time frame: Baseline and 12 months after enrollment (±2 months)
Cardiovascular Events During Follow-up
Number and proportion of participants with documented cardiovascular events during follow-up, based on available clinical records. Events will be summarized descriptively as exploratory outcomes. No formal hypothesis testing for cardiovascular event reduction is planned.
Time frame: From enrollment through 12 months (±2 months)
Healthcare Resource Utilization During Follow-up
Descriptive assessment of healthcare resource utilization during follow-up, based on available clinical records and patient-reported information when collected. The frequency and types of documented healthcare encounters will be summarized as exploratory outcomes.
Time frame: From enrollment through 12 months (±2 months)
Plan to share: Undecided — The individual participant data (IPD) sharing plan has not yet been determined. Study data will be collected and stored in a secure, institutionally managed REDCap database with restricted access and without direct personal identifiers. Any future sharing of de-identified participant-level data will require authorization from the study sponsor and relevant ethics committees, in accordance with applicable data protection regulations and institutional policies. Aggregate study findings are expected to be disseminated through scientific publications and presentations.
Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.
Of 51 observational studies under Hypercholesterolemia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran →