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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,912
- 试验地点
- 5
- 主要终点
- Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
extended statin counseling group
Extended statins counseling. Patients are handed out information leaflets on the correction of risk factors, SMS reminders.
干预措施: extended counseling (Behavioral)
convetional statin counseling group
Сounseling on the prevention of cardiovascular diseases and the use of drugs for this purpose
结局指标
主要结局
Change in the percentage of patients who achieved target LDL cholesterol level depending on the level of cardiovascular risk from baseline and 12 months
时间窗: 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
次要结局
- Assess the effect of routing and extended statin counseling on changes in treatment adherence(Baseline and Month 12)
- Change from baseline in blood pressure (mm Hg)(Baseline, Month 3, Month 6 and Month 12)
- Change from baseline in lipid levels (mmol/l)(Baseline, Month 3, Month 6 and Month 12)
- Impact of standard and extended counseling on statin therapy adherence(Baseline and Month 12)