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Influence of Additional Physician's Consultations and Short Message Service (SMS) Reminders to Patient Compliance

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04863274
Acronym
3P
Enrollment
2912
Registered
2021-04-28
Start date
2018-06-21
Completion date
2020-10-15
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipid Metabolism Disorders

Keywords

prevention of cardiovascular diseases, atorvastatin

Brief 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 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.

Interventions

DRUGatorvastatin

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.

Sponsors

National Research Center for Preventive Medicine
CollaboratorOTHER_GOV
The League of Clinical Research, Russia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Target level of LDL cholesterol12 monthsTo assess number of patients achieving the target level of low-density lipoprotein cholesterol in study group and in control group.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026