Lipid Metabolism Disorders3PNCT04863274
Influence of Additional Physician's Consultations and Short Message Service (SMS) Reminders to Patient Compliance
An observational study of Lipid Metabolism Disorders, run by The League of Clinical Research, Russia at 1 site in Russia.
Trial summary
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 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
- Lipid Metabolism Disorders
- What is being tested?
- atorvastatin
- How many people
- 2,912 participants
- Where
- 1 siteRussia
- Study dates
- 21 Jun 2018to 15 Oct 2020
- Phase
- Observational
- 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
Study population: 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
Who may be able to join
- Data on the following subjects is planned to be collected in the project:
- Aged from 40 to 65 years inclusively
- With a high (≥5%) cardiovascular risk measured by SCORE and low density lipoprotein (LDL) levels of ≥2,5 mmol/L, or with a very high (≥10%) cardiovascular risk measured by SCORE and LDL levels ≥1,8 mmol/L or With atherosclerotic stenosis of brachiocephalic arteries of >50% in the absence of cerebrovascular disease
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Program to Assess the Influence of Routing and In-depth Consultation of Patients With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance
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 retrospective part: database of patients with cardiovascular risks;
- the prospective part: observation of patients in the real world medical practice.
Read the detailed description
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.
- Conditions
- Lipid Metabolism Disorders
- Being tested
- atorvastatin
- Keywords
- prevention of cardiovascular diseases, atorvastatin
- Medical subject headings
- Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called SMS and phone call reminders, Patients' consultations
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start21 Jun 2018
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid Metabolism DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,912 participants (actual)
Sponsor and investigators
- Lead sponsor
- The League of Clinical Research, Russia
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Center for Preventive Medicine
- Responsible party
- Sponsor
- Investigators
- Svetlana I Elkonina, MD, Study director, League of Clinical Research (LeagueCRR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863274
- Sponsor's protocol ID
- Primary Prevention Program
- Acronym
- 3P
- Status last verified
- Apr 2021
- First submitted
- 20 Jan 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Program to Assess the Influence of Routing and In-depth Consultation of Patients With Cardiovascular Risk Factors on the Choice of Medicine and Treatment Compliance
- ClinicalTrials.gov ID
- NCT04863274
- Acronym / sponsor ID
- 3P / Primary Prevention Program
- Conditions
- Lipid Metabolism Disorders
- Keywords
- prevention of cardiovascular diseases, atorvastatin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,912 participants (actual)
- Lead sponsor
- The League of Clinical Research, RussiaUniversity, hospital or other
- Collaborators
- National Research Center for Preventive Medicine
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 28 Apr 2021 (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-interventional 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 world medical practice.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expanded consultation group | – | Drug: atorvastatinIn 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- Aged from 40 to 65 years inclusively
- With a high (≥5%) cardiovascular risk measured by SCORE and low density lipoprotein (LDL) levels of ≥2,5 mmol/L, or with a very high (≥10%) cardiovascular risk measured by SCORE and LDL levels ≥1,8 mmol/L or With atherosclerotic stenosis of brachiocephalic arteries of >50% in the absence of cerebrovascular disease
Key exclusion criteria (6 listed)
- 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 .
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 |
|---|---|---|
| atorvastatinAlso: SMS and phone call reminders, Patients' consultationsProfound 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. | Drug | Expanded consultation group |
Primary outcome
Target level of LDL cholesterol
Time frame: 12 months
To assess number of patients achieving the target level of low-density lipoprotein cholesterol in study group and in control group.
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 5 May 2021.
- 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.
Svetlana I Elkonina, MD study director
League of Clinical Research (LeagueCRR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipid Metabolism Disorders, run by The League of Clinical Research, Russia at 1 site 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 3 inclusion and 6 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Target level of LDL cholesterol (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 5 May 2021.