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出境医 / 临床实验 / Primary Prevention Program (3P)

Primary Prevention Program (3P)

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

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
Layout table for investigator information
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
 (submitted: April 24, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • 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
  • 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
  • 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
  • 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
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:

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

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
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.
Study Arms  ICMJE
  • Experimental: extended statin counseling group
    Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders.
    Intervention: Behavioral: extended counseling
  • No Intervention: convetional statin counseling group
    Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2019)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Study Director: Oxana M Drapkina, MD, PhD Director of National Medical Research Center for Preventive Medicine, Moscow
PRS Account National Medical Research Center for Therapy and Preventive Medicine
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP