Cholesterol Self-testing in Patients Post Acute Coronary Syndrome (C-Check)

University of Leipzig

Status: Enrolling

Conditions: Prevention; Acute Coronary Syndrome; LDL Hyperlipoproteinemia; Therapeutic Adherence

Treatments: Other: Cholesterol self-measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT06526013

BGAAF-2593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard of care

No Intervention group

Description:

Usual care according to current procedure (in patients with post acute coronary syndrome) regarding LDL target level adjustment

Cholesterol self-measurement

Experimental group

Description:

Training patients for self-monitoring of cholesterol, with independent monthly measurements and reporting of results to the study team, followed by prompt therapy adjustments

Treatment:

Other: Cholesterol self-measurement