Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target) (GoT)

Jena University Hospital

Status: Not yet enrolling

Conditions: LDL-cholesterol; ST Elevation Myocardial Infarction; Non-ST Elevation Myocardial Infarction

Treatments: Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

Study type: Interventional

Funder types: Other

Identifiers

NCT05587621

5219-07/17

Details and patient eligibility

About

Intensive Lipid-Lowering Therapy guided by a cloud-based Software System (CLIMEDO GmbH) improves (European Society of Cardiolofgy/European Atherosclerosis Society) ESC/EAS-guideline recommended LDL-cholesterol target attainment and adherence in patients with ST-Elevation Myocardial (STEMI) and Non-ST-Elevation Myocardial Infarctions (NSTEMI).

Full description

Patients admitted to the Jena University Hospital (UKS) and 9 other University hospitals in Germany with an ST-elevation or Non-ST-elevation myocardial infarction (STEMI) will be randomized to standard care or a software-based tool (CLIMEDO GmbH) to monitor low-density cholesterol (LDL-C) levels and close follow-ups to achieve ESC/EAS-guideline recommended LDL-C goals.

In this multi-center, prospective, randomized, interventional trial we propose that using a cloud-based software system (CLIMEDO GmbH) is superior to standard care in terms of LDL-C target attainment at 6 months and adherence over a time period of 12 months.

In the software group LDL-C levels will be monitored on admission, after 1,6, 12, 16, 20 weeks and after 6, 12 and 24 months. In the standard care group patients' LDL-C levels will be determined on admission after 6, 12 and 24 months. The primary endpoint is LDL-C target attainment at 6 months in both groups.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with ST- and Non-ST-elevation myocardial infarctions

Exclusion criteria

• patient without informed concent
• patients in cardiogenic shock
• patients with contraindication to lipid-lowering therapy
• patients on lipid-lowering medications on admission

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Cloud-based software

Active Comparator group

Description:

cloud-based software system (CLIMEDO GmbH) will support patients in ESC/EAS LDL-C target attainment (\< 55mg/dl/1.4 mol/L)

Treatment:

Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran

Standard Care

Placebo Comparator group

Description:

Patients will be treated by general practitioners (GPs) after hospital discharge. The discharge letter will recommend ESC/EAS dyslipidemia LDL-cholesterol targets (\< 55mg/dl/1.4 mol/L)

Treatment:

Drug: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran