A systematic collection of retrospective and prospective data based on non-intervention patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases:
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Prevention of Cardiovascular Disease | Behavioral: extended counseling | Not Applicable |
The research program will have two parts:
Stage1: identification of patients with moderate, high and very high cardiovascular risks, 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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2912 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | The Program to Assess the Influence of Routing and Extended Statin Counseling of Patient With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance |
| Actual Study Start Date : | June 21, 2018 |
| Actual Primary Completion Date : | August 28, 2019 |
| Actual Study Completion Date : | August 28, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: extended statin counseling group
Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders.
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Behavioral: extended counseling
Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
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No Intervention: convetional statin counseling group
Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose
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The method used to measure adherence included the Morisky Medication Adherence Scale (MMAS - 4).
Morisky Medication Adherence Scale is 4- item self-reported scale measuring medication taking behavior. Scores are transformed to a range of 0-4, in which higher scores reflect better adherence
| Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Men and women 40-65 years old with the presence of:
Exclusion Criteria:
| Russian Federation | |
| Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention | |
| Astrakhan, Russian Federation | |
| Nizhny Novgorod Regional Center for Medical Prevention | |
| Nizhny Novgorod, Russian Federation | |
| Regional Center for Medical Prevention | |
| Novosibirsk, Russian Federation | |
| Samara Regional Center for Medical Prevention | |
| Samara, Russian Federation | |
| Republican Center for Medical Prevention of the Republic of Bashkortostan | |
| Ufa, Russian Federation | |
| Study Director: | Oxana M Drapkina, MD, PhD | Director of National Medical Research Center for Preventive Medicine, Moscow |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | February 12, 2019 | ||||||
| First Posted Date ICMJE | April 25, 2019 | ||||||
| Last Update Posted Date | September 10, 2019 | ||||||
| Actual Study Start Date ICMJE | June 21, 2018 | ||||||
| Actual Primary Completion Date | August 28, 2019 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months [ Time Frame: 12 months ] The primary objective of this study is to assess the influence of routing and extended statin counseling of patients with cardiovascular risk factors on the change in the percentage of patients who achieved target LDL cholesterol level from baseline through 12 months
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Primary Prevention Program | ||||||
| Official Title ICMJE | The Program to Assess the Influence of Routing and Extended Statin Counseling of Patient With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance | ||||||
| Brief Summary |
A systematic collection of retrospective and prospective data based on non-intervention patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases:
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| Detailed Description |
The research program will have two parts: Stage1: identification of patients with moderate, high and very high cardiovascular risks, 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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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Primary Prevention of Cardiovascular Disease | ||||||
| Intervention ICMJE | Behavioral: extended counseling
Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
2912 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | August 28, 2019 | ||||||
| Actual Primary Completion Date | August 28, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: Men and women 40-65 years old with the presence of:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 40 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Russian Federation | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03927196 | ||||||
| Other Study ID Numbers ICMJE | 03-01/18 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | National Medical Research Center for Therapy and Preventive Medicine ( National Research Center for Preventive Medicine ) | ||||||
| Study Sponsor ICMJE | National Research Center for Preventive Medicine | ||||||
| Collaborators ICMJE | The League of Clinical Research, Russia | ||||||
| Investigators ICMJE |
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| PRS Account | National Medical Research Center for Therapy and Preventive Medicine | ||||||
| Verification Date | September 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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