Coronary Artery DiseaseBOLTNCT06897566
Barriers to Optimal LDL-C Targets in Patients With Atherosclerotic Cardiovascular Disease
An observational study of Coronary Artery Disease and Statin Adverse Reaction, run by Cairo University at 2 sites in Egypt.
Trial summary
In the present cross-sectional observational study, the investigators aimed to: Evaluate the prevalence of achievement of LDL-C targets among a sample of Egyptian ASCVD patients. Attempt to unveil the potential barriers to achieve LDL-C goals in order to determine the appropriate corrective actions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Statin Adverse Reaction, LDL Level
- What is being tested?
- Fasting lipid profile
- How many people
- 1,000 participants
- Where
- 2 sitesEgypt
- Study dates
- 21 Sep 2024to 1 Nov 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with established ASCVD with indication for high-intensity statin for a period 6 months This includes patients with coronary artery disease, peripheral arterial disease, cerebrovascular disease.
Who may be able to join
- Patients presenting to cardiology department/ outpatient clinic.
- Established ASCVD and eligible for high intensity statins for at least six-months.
- Age between18-to-80y.
Who cannot join
- Refusal to participate in the survey.
- Recent diagnosis of ASCVD with indication to high intensity statins for a period < six-months.
- Patients with medical limitation or contraindications to statins therapy.
- Patients with documented diagnosis of homozygous familial hypercholesterolemia.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Medicine Cairo University
Cairo
Faculty of Medicine, Cairo University
Cairo
About this study
Official title: Evaluation of Adherence to Cholesterol Therapies and Identification of Barriers to Optimal LDL-C Targets in Patients With Atherosclerotic Cardiovascular Disease
In the present cross-sectional observational study, the investigators aimed to:
- Evaluate the prevalence of achievement of LDL-C targets among a sample of Egyptian ASCVD patients.
- Attempt to unveil the potential barriers to achieve LDL-C goals in order to determine the appropriate corrective actions.
Read the detailed description
There is a huge gap between guideline recommendations and real-world data concerning LDL-C targets for coronary artery disease CAD patients. This large gap highlights the need to improve the utilization of high-intensity statins and other non-statin therapies. This dictates evaluating the reasons for underutilization of statin and non-statin therapies, as well as understanding the barriers to achieving optimal LDL-C targets. Although there are few attempts to document and analyze this gap, all of them come from the Western world while data from the Middle East are sparse.
This cross-sectional observational study to evaluate the prevalence of achievement of LDL-C targets among a sample of Egyptian CAD patients. Also potential barriers to LDL-C goals will be sought in order to determine the appropriate corrective actions.
- Population of study: Patients with ASCVD and eligible for high-intensity statin therapy for a period of 6-months or more.
- Study location: Cairo University hospitals.
- Inclusion criteria:
- Patients presenting to cardiology department/ outpatient clinic.
- Established ASCVD and eligible for high intensity statins for at least six-months.
- Age between18-to-80y.
- Exclusion criteria:
- Refusal to participate in the survey.
- Patients with medical limitation or contraindications to statins therapy.
- Patients with documented diagnosis of homozygous familial hypercholesterolemia.
- Methodology in details:
Patients meeting the eligibility criteria will be offered to participate in the online survey tool through their smart phones. The link and the QR-code for the tool will be offered to the patient, and assistance will be offered to resolve any ambiguity of the questions if needed.
The patient would respond to the 38-item questionnaire comprising the study tool that can be accessed by their phones.
https://forms.office.com/r/xni4uNWKGg and a QR-code (can not be pasted to this text box) was available for swift and easy access.
Data were automatically pooled into an electronic online database for analysis upon study completion.
- Confidentiality of data: Clinical data will be tabulated by number codes that will be anonymized. Only treating physicians will have access to participants identities, while the anonymized tabulated data will be available for the statisticians.
- Study outcomes:
- Primary outcome parameters Prevalence of achievement of recommended LDL-C targets among patients with established ASCVD.
- Secondary outcome parameters Identify potential barriers to achieve LDL-C targets.
- Sample size This survey is planned to be completed when 1000 ASCVD patients finish their participation to the online survey tool.
- Statistical analysis Statistical package for social science (SPSS) software, version 22 for Microsoft Windows (SPSS Inc., Chicago, IL, USA) will be used for data analysis. Categorical data will be presented as frequency and percentages (n (%)) and correlations among them will be analyzed by chi square test. Continuous data will be checked for normality using Shapiro-Wilk test and will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Continuous data will be analyzed using one-way analysis of variance (ANOVA). Repeated measures will be analyzed using analysis of variance (ANOVA) for repeated measures with post-hoc pairwise comparisons using the Tukey and Bonferroni tests. A probability p value less than 0.05 will be considered statistically significant.
- Source of funding:
- None
- Conditions
- Coronary Artery Disease, Statin Adverse Reaction, LDL Level
- Being tested
- Fasting lipid profile
- Keywords
- coronary artery disease, LDL-C, statins, statin intolerance, statin associated muscle symptoms
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting lipid profileDiagnostic test
Recruited patients will be requested to provide data from their most recent fasting lipid profile
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of achievement of recommended LDL-C targets among patients with established ASCVD
Recruited patients will be stratified according to the LDL-C levels into those <55, <70, <100, <130, and above.
Patients in different LDL-C strata will be surveyed. Predictors for failure of achievement of LDL-C goals will be sought.
Measured: Being a cross sectional study selectively recruiting patients with established indication for >6months, the study will accept a fasting lipid profile that was performed within 1 month from surveying the recruited patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start21 Sep 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Samir, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897566
- Sponsor's protocol ID
- MS1462021
- Acronym
- BOLT
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Adherence to Cholesterol Therapies and Identification of Barriers to Optimal LDL-C Targets in Patients With Atherosclerotic Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06897566
- Acronym / sponsor ID
- BOLT / MS1462021
- Conditions
- Coronary Artery Disease, Statin Adverse Reaction, LDL Level
- Keywords
- coronary artery disease, LDL-C, statins, statin intolerance, statin associated muscle symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 27 Mar 2025 (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.
In the present cross-sectional observational study, the investigators aimed to:
- Evaluate the prevalence of achievement of LDL-C targets among a sample of Egyptian ASCVD patients.
- Attempt to unveil the potential barriers to achieve LDL-C goals in order to determine the appropriate corrective actions.
Detailed description
There is a huge gap between guideline recommendations and real-world data concerning LDL-C targets for coronary artery disease CAD patients. This large gap highlights the need to improve the utilization of high-intensity statins and other non-statin therapies. This dictates evaluating the reasons for underutilization of statin and non-statin therapies, as well as understanding the barriers to achieving optimal LDL-C targets. Although there are few attempts to document and analyze this gap, all of them come from the Western world while data from the Middle East are sparse.
This cross-sectional observational study to evaluate the prevalence of achievement of LDL-C targets among a sample of Egyptian CAD patients. Also potential barriers to LDL-C goals will be sought in order to determine the appropriate corrective actions.
- Population of study: Patients with ASCVD and eligible for high-intensity statin therapy for a period of 6-months or more.
- Study location: Cairo University hospitals.
- Inclusion criteria:
- Patients presenting to cardiology department/ outpatient clinic.
- Established ASCVD and eligible for high intensity statins for at least six-months.
- Age between18-to-80y.
- Exclusion criteria:
- Refusal to participate in the survey.
- Patients with medical limitation or contraindications to statins therapy.
- Patients with documented diagnosis of homozygous familial hypercholesterolemia.
- Methodology in details:
Patients meeting the eligibility criteria will be offered to participate in the online survey tool through their smart phones. The link and the QR-code for the tool will be offered to the patient, and assistance will be offered to resolve any ambiguity of the questions if needed.
The patient would respond to the 38-item questionnaire comprising the study tool that can be accessed by their phones.
https://forms.office.com/r/xni4uNWKGg and a QR-code (can not be pasted to this text box) was available for swift and easy access.
Data were automatically pooled into an electronic online database for analysis upon study completion.
- Confidentiality of data: Clinical data will be tabulated by number codes that will be anonymized. Only treating physicians will have access to participants identities, while the anonymized tabulated data will be available for the statisticians.
- Study outcomes:
- Primary outcome parameters Prevalence of achievement of recommended LDL-C targets among patients with established ASCVD.
- Secondary outcome parameters Identify potential barriers to achieve LDL-C targets.
- Sample size This survey is planned to be completed when 1000 ASCVD patients finish their participation to the online survey tool.
- Statistical analysis Statistical package for social science (SPSS) software, version 22 for Microsoft Windows (SPSS Inc., Chicago, IL, USA) will be used for data analysis. Categorical data will be presented as frequency and percentages (n (%)) and correlations among them will be analyzed by chi square test. Continuous data will be checked for normality using Shapiro-Wilk test and will be presented as mean (standard deviation) or median (interquartile range) as appropriate. Continuous data will be analyzed using one-way analysis of variance (ANOVA). Repeated measures will be analyzed using analysis of variance (ANOVA) for repeated measures with post-hoc pairwise comparisons using the Tukey and Bonferroni tests. A probability p value less than 0.05 will be considered statistically significant.
- Source of funding:
- None
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with established ASCVD with indication for high-intensity statin for a period 6 months This includes patients with coronary artery disease, peripheral arterial disease, cerebrovascular disease.
Key inclusion criteria (3 listed)
- Patients presenting to cardiology department/ outpatient clinic.
- Established ASCVD and eligible for high intensity statins for at least six-months.
- Age between18-to-80y.
Key exclusion criteria (4 listed)
- Refusal to participate in the survey.
- Recent diagnosis of ASCVD with indication to high intensity statins for a period < six-months.
- Patients with medical limitation or contraindications to statins therapy.
- Patients with documented diagnosis of homozygous familial hypercholesterolemia.
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 |
|---|---|---|
| Fasting lipid profileRecruited patients will be requested to provide data from their most recent fasting lipid profile | Diagnostic test | – |
Primary outcome
Prevalence of achievement of recommended LDL-C targets among patients with established ASCVD
Time frame: Being a cross sectional study selectively recruiting patients with established indication for >6months, the study will accept a fasting lipid profile that was performed within 1 month from surveying the recruited patient.
Recruited patients will be stratified according to the LDL-C levels into those <55, <70, <100, <130, and above. Patients in different LDL-C strata will be surveyed. Predictors for failure of achievement of LDL-C goals will be sought.
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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Statin Adverse Reaction, run by Cairo University at 2 sites in Egypt.
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 3 inclusion and 4 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 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Prevalence of achievement of recommended LDL-C targets among patients with established ASCVD (time frame: Being a cross sectional study selectively recruiting patients with established indication for >6months, the study will accept a fasting lipid profile that was performed within 1 month from surveying the recruited patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.