Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526013
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cholesterol Self-testing in Patients Post Acute Coronary Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
C-Check
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None