Clinical trial NCT06526013: Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
Official title: Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
Prevention
LDL Hyperlipoproteinemia
Therapeutic Adherence
Keywords: Acute Coronary Syndrome
Dyslipidemia
Statin
Lipid lowering therapy
Cardiovascular disease
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After randomization into the intervention arm versus control, patients in the intervention group will receive a device for self-measurement and will be trained in its use. Subsequently, these patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. The control group will attend scheduled visits at months 6 and 12, where medication adjustments can be made, as has been done in the outpatient clinic up to now
Primary purpose: PREVENTION

Brief summary: The pharmacological reduction of LDL-C lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. The achievement of LDL-C target levels in Germany, Europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. Only a small proportion of post-myocardial infarction patients reach their LDL-C target range within a year. There is a significant need for new strategies to improve LDL-C target achievement and thereby reduce the occurrence of secondary cardiovascular events.

The aim of the study is to establish a basis for improving prevention by achieving the target LDL level effectively and quickly in patients with high and very high cardiovascular risk profiles.

Detailed description: In this randomized study, the investigators aim to investigate whether additional self-monitoring of cholesterol values by patients leads to more effective LDL reduction and quicker achievement of the target LDL range versus usual care.

This study systematically and prospectively examines the benefits of self-monitoring and control of cholesterol levels for the first time.

The patients in the intervention arm will receive a device for self-measurement of cholesterol values and will be trained in its use. These patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. The control arm is treated according to local standards, which includes control of the cholesterol values twice a year at the visit in out-patient clinic. Patients in both study arms will be followed up for at least 12 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients with acute coronary syndrome in the last 6 months and not having reached the LDL target value
* Signed informed consent

Exclusion Criteria:

* Persons unable to understand the study
* Persons unable or unwilling to perform self-measurements
* Persons unable or unwilling to undergo additional cholesterol-lowering therapy to reach the LDL target
* Pre-menopausal women without contraception
* Use of experimental drugs or investigational products within 30 days prior to screening
* Employees or contractors of the institution conducting the study or family members of the Principal Investigator, Co-Investigator, or financial supporter

Primary outcomes:
measure: percentage value LDL-Cholesterol reduction in comparison to baseline
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Clinic of cardiology University clinic Leipzig
state: Saxony
Study officials:
affiliation: University Clinik, Clinic for Cardiology Leipzig
name: Ulrich Laufs, Professor
role: STUDY_CHAIR
References:
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