Lipid Management Gaps in Mexican Patients at High and Very High Cardiovascular Risk
NCT07930975, Not yet recruiting, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Lipid Management Gaps in Mexican Patients at High and Very High Cardiovascular Risk | ClinicalTrials.gov |
| NCT number | NCT07930975 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 1,600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | ClinicalTrials.gov |
| Conditions | Dyslipidemias, Hypercholesterolemia, Cardiovascular Diseases | ClinicalTrials.gov |
| Interventions | Lipid-Lowering Therapy in Routine Clinical Practice | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Participants Achieving Risk-Based LDL-C Treatment Goals | Baseline (at enrollment; LDL-C measurement obtained within the preceding 12 months) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Achieving Risk-Based LDL-C Goals at 12 Months | 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Secondary | Lipid-Lowering Treatment Patterns at Baseline and Follow-up | Baseline and 12 months (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Lipid-Lowering Treatment Intensification | From enrollment to 12 months (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Clinical Inertia in Lipid-Lowering Treatment | From enrollment through 12 months (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Changes in Lipid Parameters From Baseline to 12 Months | Baseline and 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Barriers to Lipid-Lowering Treatment Optimization | Baseline and 12 months after enrollment (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With High Medication Adherence | Baseline and 12 months after enrollment (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants With Documented Statin Intolerance | Baseline and 12 months after enrollment (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months | Baseline and 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Secondary | Change in High-Sensitivity C-Reactive Protein From Baseline to 12 Months | Baseline and 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Secondary | Change in Serum Creatinine From Baseline to 12 Months | Baseline and 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Secondary | Change in Health-Related Quality of Life Assessed by EQ-5D-5L | Baseline and 12 months after enrollment (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Change in Patient Activation Measure (PAM-13) Score | Baseline and 12 months after enrollment (±2 months) | 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. | ClinicalTrials.gov |
| Secondary | Change in Estimated Glomerular Filtration Rate From Baseline to 12 Months | Baseline and 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Secondary | Change in Urinary Albumin-to-Creatinine Ratio From Baseline to 12 Months | Baseline and 12 months after enrollment (±2 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. | ClinicalTrials.gov |
| Other | Cardiovascular Events During Follow-up | From enrollment through 12 months (±2 months) | 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. | ClinicalTrials.gov |
| Other | Healthcare Resource Utilization During Follow-up | From enrollment through 12 months (±2 months) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.