Primary Prevention of Cardiovascular Disease3PNCT03927196
Primary Prevention Program
A study testing extended counseling in people with Primary Prevention of Cardiovascular Disease, run by National Research Center for Preventive Medicine at 5 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Primary Prevention of Cardiovascular Disease
- What is being tested?
- extended counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,912 participants
- Where
- 5 sitesRussia
- Study dates
- 21 Jun 2018to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Deputy Chief Medical Officer for Prevention at the Center for Medical Prevention
Astrakhan
Nizhny Novgorod Regional Center for Medical Prevention
Nizhny Novgorod
Regional Center for Medical Prevention
Novosibirsk
Samara Regional Center for Medical Prevention
Samara
Republican Center for Medical Prevention of the Republic of Bashkortostan
Ufa
About this study
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
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
Read the 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
- Being tested
- extended counseling
- Keywords
- primary prevention, cardiovascular risk, hyperlipidaemia, adherence
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extended counselingBehavioural
Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
| Study group | Role | What they receive |
|---|---|---|
| extended statin counseling group | Experimental | Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders. Receives: Behavioral: extended counseling |
| convetional statin counseling group | No intervention | Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 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
Measured: 12 months
Secondary outcomes (4)
Assess the effect of routing and extended statin counseling on changes in treatment adherence
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
Measured: Baseline and Month 12
Change from baseline in lipid levels (mmol/l)
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
Measured: Baseline, Month 3, Month 6 and Month 12
Change from baseline in blood pressure (mm Hg)
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
Measured: Baseline, Month 3, Month 6 and Month 12
Impact of standard and extended counseling on statin therapy adherence
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
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start21 Jun 2018
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Prevention of Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- The League of Clinical Research, Russia
- Responsible party
- Sponsor
- Investigators
- Oxana M Drapkina, MD, PhD, Study director, Director of National Medical Research Center for Preventive Medicine, Moscow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927196
- Sponsor's protocol ID
- 03-01/18
- Acronym
- 3P
- Status last verified
- Sep 2019
- First submitted
- 12 Feb 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03927196
- Acronym / sponsor ID
- 3P / 03-01/18
- Keywords
- primary prevention, cardiovascular risk, hyperlipidaemia, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,912 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Collaborators
- The League of Clinical Research, Russia
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| extended statin counseling group | Experimental | Behavioral: extended counselingExtended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders. |
| convetional statin counseling group | No intervention | –Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extended counselingPatients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling. | Behavioural | extended statin counseling group |
Primary outcome
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
4 secondary outcomes
Assess the effect of routing and extended statin counseling on changes in treatment adherence
Time frame: Baseline and Month 12
Change from baseline in lipid levels (mmol/l)
Time frame: Baseline, Month 3, Month 6 and Month 12
Change from baseline in blood pressure (mm Hg)
Time frame: Baseline, Month 3, Month 6 and Month 12
Impact of standard and extended counseling on statin therapy adherence
Time frame: Baseline and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oxana M Drapkina, MD, PhD study director
Director of National Medical Research Center for Preventive Medicine, Moscow
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing extended counseling in people with Primary Prevention of Cardiovascular Disease, run by National Research Center for Preventive Medicine at 5 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.