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Primary Prevention Program (3P)

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ClinicalTrials.gov Identifier: NCT03927196
Recruitment Status : Completed
First Posted : April 25, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
The League of Clinical Research, Russia
Information provided by (Responsible Party):
National Research Center for Preventive Medicine

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:

  • the retrospective part: database of patients with cardiovascular risks;
  • the prospective part: observation of patients in the real medical practice

Condition or disease Intervention/treatment Phase
Primary Prevention of Cardiovascular Disease Behavioral: extended counseling Not Applicable

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 : 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

Resource links provided by the National Library of Medicine


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.
Behavioral: extended counseling
Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.

No Intervention: convetional statin counseling group
Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Assess the effect of routing and extended statin counseling on changes in treatment adherence [ Time Frame: Baseline and Month 12 ]

    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


  2. Change from baseline in lipid levels (mmol/l) [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ]
    To evaluate the impact of extended statin counseling on change of CVD risk factors (lipid levels) in patients with moderate, high and very high risk. Measurement of lipid levels at baseline and after 3,6,12 months

  3. Change from baseline in blood pressure (mm Hg) [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ]
    To evaluate the impact of standard and extended counseling on change of CVD risk factors (blood pressure). Measurement of blood pressure (mm Hg) at baseline and after 3,6,12 months

  4. Impact of standard and extended counseling on statin therapy adherence [ Time Frame: Baseline and Month 12 ]
    The method used to measure adherence was KAP test. KAP test is the specially designed questionnaire for this study includes 14 questions, in patients with hyperlipidemia. KAP test summary score is an assessment of patients' knowledge about high cholesterol, their attitude to this problem and the application of this knowledge. Higher scores reflect better indicators of knowledge, attitudes and practices



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Men and women 40-65 years old with the presence of:

  • moderate cardiovascular risk (<5% but ≥1% on a SCORE scale) and cholesterol level LDL ≥3.0 mmol / l, in which the target is not reached during the improvement of lifestyle level of cholesterol-LDL, and the attending physician considers appropriate the appointment lipid-lowering drugs (statins), or
  • high cardiovascular risk (≥5% but <10% on a SCORE scale) and cholesterol level LDL ≥ 2.5 mmol / l, or
  • very high cardiovascular risk (≥10% on the SCORE scale) and cholesterol-LDL ≥1.8mmol / l, or
  • atherosclerotic stenosis of the brachiocephalic arteries> 50% in the absence cerebrovascular diseases and the level of cholesterol-LDL ≥1.8 mmol / l, which do not have contraindications to taking statins and not taking drugs of this group in currently.

Exclusion Criteria:

  • The presence of the following clinically significant events in anamnesis: myocardial infarction, stroke, myocardial infarction
  • The presence of the following diseases at the time of statin administration: ischemic heart disease; heart failure; atherosclerotic disease of peripheral arteries; atherosclerotic stenosis of the brachiocephalic arteries in the presence of cerebrovascular disease; chronic renal failure with creatinine clearance <30 ml / min; liver disease with an increase in AST and ALT levels of more than 3 times, compared to the upper limit of normal; history of muscular or neuromuscular diseases, with elevated CPK; alcoholism, oncological, mental and other severe concomitant diseases; intolerance to statins in anamnesis; use of other lipid-modifying agents.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927196


Locations
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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
Sponsors and Collaborators
National Research Center for Preventive Medicine
The League of Clinical Research, Russia
Investigators
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Study Director: Oxana M Drapkina, MD, PhD Director of National Medical Research Center for Preventive Medicine, Moscow

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Responsible Party: National Research Center for Preventive Medicine
ClinicalTrials.gov Identifier: NCT03927196     History of Changes
Other Study ID Numbers: 03-01/18
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by National Research Center for Preventive Medicine:
primary prevention
cardiovascular risk
hyperlipidaemia
adherence
Additional relevant MeSH terms:
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Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents