Primary Prevention Program

Primary Prevention of Cardiovascular Disease Clinical Trial

— 3P  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927196
• Other study ID #: 03-01/18
• Status: Completed
• Phase: N/A
• Start date: June 21, 2018
• Est. completion date: August 28, 2019

Study information

• Verified date: September 2019
• Source: National Research Center for Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 real medical practice

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2912
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Primary Prevention of Cardiovascular Disease

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine	The League of Clinical Research, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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	Baseline and Month 12
Secondary	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	Baseline, Month 3, Month 6 and Month 12
Secondary	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	Baseline, Month 3, Month 6 and Month 12
Secondary	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	Baseline and Month 12