NCT05587621

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

"Intensive Lipid-Lowering Therapy Guided by a Cloud-based Software System (CLIMEDO GmbH) in Patients With ST-Elevation and Non-ST-Elevation Myocardial Infarctions" (Germany on Target)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Jena University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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.

Conditions

• ST Elevation Myocardial Infarction
• Non-ST Elevation Myocardial Infarction
• LDL-cholesterol

Interventions

Type	Name	Description
DRUG	statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran	dietary advice for low cholesterol food

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2022-10-20
• Last updated: 2024-03-07

Locations

10 sites across 1 country: Germany