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| Name | Class |
|---|---|
| National Research Center for Preventive Medicine | OTHER_GOV |
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A systematic collection of retrospective and prospective data based on non-interventional patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases:
The research program will have two parts:
Stage 1: identification of patients with moderate, high and very high cardiovascular risk, not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs.
Stage 2: a prospective observation of patients receiving primary medical prophylaxis of CVD with atorvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expanded consultation group | In an expanded consultation group is being conducted in the study group on the importance of primary prevention of cardiovascular diseases and on the reduction of cardiovascular risk by taking statins. Patients are given brochures and information materials on the risk factors for cardiovascular diseases and the possibility of their correction. Also, the patients of the study group are regularly reminded (2 times a month) with the help of SMS mailings and calls of health workers about the need to follow the doctor's recommendations for taking atorvastatin and returning to the medical institution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atorvastatin | Drug | Profound patients' consultations (different from standard practice) on the importance of primary prevention of cardiovascular diseases, including preventive administration of statins. Subjects in profound consultation group will receive regular reminders (2 times a month) via SMS and phone calls to check following the doctor's recommendations and remind about follow-up visit to study centre. |
| Measure | Description | Time Frame |
|---|---|---|
| Target level of LDL cholesterol | To assess number of patients achieving the target level of low-density lipoprotein cholesterol in study group and in control group. | 12 months |
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Inclusion criteria:
Data on the following subjects is planned to be collected in the project:
Exclusion criteria:
No contraindications to statin treatment and not taking stating at study entry.
History of the following clinically significant events and conditions:
(а) myocardial infarction (б) stroke (в) transient ischemic attack
Presence of the following diseases at the time of a statin administration:
(а) ischemic heart disease (б) heart failure (в) peripheral artery atherosclerosis (г) atherosclerotic stenosis of brachiocephalic arteries with cerebrovascular disease .
Subjects must give their consent for processing of their personal data for the purposes of this scientific project.
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The total population of patients (2912 people) will be divided into three strata:
patients with moderate risk of CVD (1242 patients) patients with high risk of CVD (1044 patients) patients with very high risk of CVD (626 patients). The subjects are randomized to a study or control group in each stratum in the ratio of 1: 1
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| Name | Affiliation | Role |
|---|---|---|
| Svetlana I Elkonina, MD | League of Clinical Research (LeagueCRR) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| League of Clinical Research (LeagueCRR) | Moscow | 119590 | Russia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 15, 2023 | |
| Reset | May 30, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2018 | Jan 20, 2021 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 15, 2023 | May 30, 2024 |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D013097 | Spermine Synthase |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D019883 | Alkyl and Aryl Transferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |