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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00012884 |
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Date of registration:
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17/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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EU-Wide Cross-Sectional Observational Study of
Lipid-Modifying Therapy Use in Secondary and
Primary Care DA VINCI
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Scientific title:
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EU-Wide Cross-Sectional Observational Study of
Lipid-Modifying Therapy Use in Secondary and
Primary Care DA VINCI - DA VINCI |
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Date of first enrolment:
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01/11/2017 |
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Target sample size:
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6000 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00012884 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Austria
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Belgium
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Czechia
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Denmark
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France
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Germany
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Greece
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Hungary
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Ireland
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Italy
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Netherlands
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Poland
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Romania
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Slovakia
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Spain
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Sweden
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Ukraine
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United Kingdom
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Contacts
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Name:
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Johanna
Sukumar |
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Address:
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Stadium House, 68 Wood Lane
W12 7RH
London
United Kingdom |
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Telephone:
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+44 (0) 207 594 2594 |
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Email:
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j.sukumar@imperial.ac.uk |
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Affiliation:
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Imperial College London |
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Name:
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Johanna
Sukumar |
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Address:
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Stadium House, 68 Wood Lane
W12 7RH
London
United Kingdom |
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Telephone:
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+44 (0) 207 594 2594 |
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Email:
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j.sukumar@imperial.ac.uk |
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Affiliation:
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Imperial College London |
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Key inclusion & exclusion criteria
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Inclusion criteria: Inclusion Criteria
• LDL-C measurement within 14 months of enrolment, obtained independently of
participation in a clinical trial
• Use of any LMT (may include statin/ezetimibe/fibrate/PCSK9 inhibitor/bile acid
absorption inhibitor/nicotinic acid/other) at time of enrolment, or any LMT
prescribed within 12 months prior to date of enrolment, or any LMT prescribed at
date of enrolment
• Age = 18 years at enrolment
• Provided informed consent/notified according to local requirements
• Subject expected to survive for at least 1 year after enrolment
Exclusion criteria: Exclusion Criteria
• Diagnosis of FH and with history of CV event
• Currently receiving therapy for carcinoma (excepting squamous epithelial cell)
• Known HIV positive status
• Pregnant or breastfeeding at time of enrolment
• Participating in an interventional clinical trial within 6 months prior to enrolment
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lipid-Modifying Therapy
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Intervention(s)
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Group 1: This is an observational study. All patients will be observed as one group. Therefore the methodology description for this research is a case note review, cross-sectional study with a questionnaire for patients to complete PAM- 13 (Patient Activation Measure)
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Primary Outcome(s)
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LDL-C measurement most recent to enrolment (within previous 14 months)
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Secondary Outcome(s)
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Secondary outcome measure:
• Lipid levels (total cholesterol, non-HDL-C, HDL, triglycerides, Lp(a), apo B100,
apo A1) most recent to enrolment (within previous 14 months)
• Use of LMT (type, dose, frequency) including combination therapy, in 12 months
prior to enrolment, up to and including enrolment date
• Clinical characteristics at time of enrolment as assessed in relation to:
- FH status (diagnosed/ not diagnosed)
- CV history
- Diabetic status (diabetic/not diabetic; Type 1 or Type II)
- CKD status
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Source(s) of Monetary Support
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AMGEN LTD
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Ethics review
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Status: Approved
Approval date: 23/08/2017
Contact:
gs-ek@uni-koeln.de
Ethikkommission der Medizinischen Fakultät der Universität zu Köln
+49-221-478 82900
gs-ek@uni-koeln.de
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