Intensive Lipid-lowering in Patients With STEMI and NSTEMI (Germany on Target)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran.
- Who it may be relevant to
- Registry conditions: ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction, LDL-cholesterol. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"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)
Overview
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.
Interventions
- Drug statins, ezetimibe, bempedoic acid, evolocumab, alirocumab, inclisiran
dietary advice for low cholesterol food
Primary outcome measures
- LDL-C [Time frame: 6 months]
Secondary outcome measures (2)
- side-effects of lipid lowering therapy [Time frame: 6 months]
- adherence to LLT [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Germany · 10 centers
- University Hospital Jena — Jena
- Universitätsmedizin Berlin — Berlin
- Universitätsklinikum Dresden — Dresden
- Universitätsklinikum Essen — Essen
- Universitätsklinikum Frankfurt — Frankfurt
- Universitätsklinikum Freiburg — Freiburg im Breisgau
- Universitätsklinikum Halle — Halle
- Universitätsklinikum des Saarlandes — Homburg
- … and 2 more centers
Identifiers
NCT: NCT05587621 · 5219-07/17