NCT Number: NCT07835282
Germany on Target Registry (DaZiR) is a prospective, Germany-wide patient registry designed to assess lipid management and low-density lipoprotein cholesterol ( LDL-C) target attainment in adults following acute myocardial infarction (STEMI or NSTEMI).
Eligible patients are informed about the registry by treating physicians or their medical teams and receive an individual access link or QR code. Following electronic informed consent and registration, participants provide clinical and follow-up information through the brite™ platform.
Clinical data, including LDL-C values and lipid-lowering treatment, can be entered by the participants or obtained from uploaded medical documents. The platform enables participants to follow the course of their LDL-C values and provides reminders for scheduled follow-up data collection.
Medical treatment is determined independently by the treating physicians as part of routine clinical care and is not assigned by the registry. The registry aims to assess LDL-C target attainment over time, changes in lipid-lowering treatment, treatment adherence and cardiovascular outcomes following myocardial infarction.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Germany on Target Registry is a prospective patient registry investigating lipid management and cardiovascular secondary prevention following acute myocardial infarction in Germany.
Adults following ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) may be informed about the registry by participating physicians and medical institutions. The role of the physicians is primarily limited to identifying potentially eligible patients, providing information about the registry and supplying an individual access link or QR code.
Following registration and electronic informed consent, further study participation is conducted through the Brite™ digital platform provided by XO Life. Participants provide follow-up information directly through the platform. Relevant laboratory values can be entered manually or obtained from medical documents uploaded by the participant.
Baseline information includes characteristics of the index myocardial infarction, LDL-C values at admission and/or discharge, lipid-lowering treatment and relevant cardiovascular risk factors and laboratory parameters. Follow-up assessments document LDL-C values, changes in lipid-lowering therapy and additional clinical information.
The primary focus of the registry is the proportion of participants achieving the predefined LDL-C target of <55 mg/dL and the maintenance of LDL-C target attainment during follow-up.
Secondary objectives include characterization of the longitudinal LDL-C course, changes and escalation of lipid-lowering therapy, treatment adherence, reported suspected adverse drug reactions and cardiovascular events during follow-up.
The registry does not prescribe a specific lipid-lowering treatment or modification of treatment. Decisions regarding pharmacological treatment remain the responsibility of the participant's treating physicians and are made according to routine clinical care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants receive medical care according to routine clinical practice. The registry does not prescribe or assign lipid-lowering treatment. Lipid-lowering therapies and subsequent treatment changes are documented as part of the observational data collection.
Time frame: 12 months
The primary endpoint of the study/registry is the achievement and maintenance of the LDL-C target level recommended by the current ESC/EAS guidelines for high-risk cardiovascular patients during the follow-up period. Assessment is based on documented LDL-C measurements taken at specified time points (after 6 weeks, 3, 6, and 12 months, as well as during the subsequent long-term follow-up).
Time frame: Baseline to 60 month
Absolute change in LDL cholesterol concentration from the baseline or discharge value to the predefined follow-up assessments.
Unit: mg/dL
Time frame: Baseline to 60 Month
Percentage change in LDL cholesterol concentration from the baseline or discharge value to the predefined follow-up assessments.
Unit: %
Time frame: Baseline
Body weight documented for registry participants. Unit: kg
Time frame: Baseline
Body height documented for registry participants. Unit: cm
Time frame: Baseline
Body mass index calculated from documented body weight and height. Unit: kg/m²
Time frame: Baseline to 60 month
High-density lipoprotein cholesterol (HDL) cholesterol concentration documented during registry follow-up.
Unit: mg/dL
Time frame: Baseline to 60 mionth
Triglyceride concentration documented during registry follow-up.
Time frame: Baseline
Lipoprotein(a) concentration documented during registry follow-up. Unit: nmol/L or mg/dL
Time frame: Baseline to 60 month
Glycated hemoglobin (HbA1c) value documented during registry follow-up. Unit: %
Time frame: Baseline to 60 month
High-sensitivity C-reactive protein (hsCRP) concentration documented during registry follow-up.
Unit: mg/L
Time frame: Baseline
Systolic and diastolic blood pressure documented during registry follow-up. Unit: mmHg
Time frame: Baseline to 60 month
Proportion of participants with a documented change in lipid-lowering therapy during follow-up, including initiation, discontinuation, substitution, or modification of lipid-lowering medication.
Time frame: Baseline to 60 month
Proportion of participants with documented intensification of lipid-lowering therapy during follow-up.
Time frame: Baseline to 60 month
Participant-reported adherence to prescribed lipid-lowering therapy during registry follow-up.
Time frame: Baseline to 60 month
Proportion of participants experiencing at least one cardiovascular event during registry follow-up. Cardiovascular events are defined as recurrent ST-elevation myocardial infarction (STEMI), recurrent non-ST-elevation myocardial infarction (NSTEMI), ischemic stroke, or unplanned coronary revascularization.
Contact information is provided by the study sponsor or research team.
Lukas Babylon, Dr. rer. nat.
CONTACT
Oliver Weingärtner, Prof. Dr. med.
CONTACT
Deutsche Gesellschaft für Lipidologie e. V. (DGFL) - Lipid-Liga
Other
Acronym: DaZiR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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