A Randomized and Controlled Study About the Impact of Intensive Education on Lipid Management in Patients With Acute Coronary Syndrome in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,568
- 试验地点
- 5
- 主要终点
- LDL-C target achieving rate
研究概览
简要总结
Among the patients with coronary heart disease, those with ACS (acute coronary syndrome) are extremely high-risk patients. Therefore, management outside hospital, especially the regular administration of drugs, is vital to prevent the recurrence of cardiovascular events. However, most patients often fail to stay on a long-term administration regimen, especially the administration of statins. According to the statistics, the average duration adhered with statin in patients with ACS is less than 3 months, use of statin at hospital discharge was only 80% and 65% in 6 month, with a very low LDL-C control rate (about 11% at 6 months), which poses a threat to the recurrence rate of cardiovascular events in patients with ACS.
It was found in previous studies that there were many factors influencing patients' compliance, in which patients' refusing to take medicine accounted for a higher proportion. It suggests that patient had not recognized the importance of long-term administration. Therefore, it is extremely important for physicians to strengthen patient education and regular follow-up visits during disease management. Moreover, the effectiveness of patient education during chronic disease management has already been proved in some studies abroad, and the interventional effect of multiple patient education process outweighs that of single approach education.
Thus, we intend to conduct a randomized and controlled study to explore the effect of multi-channel intensive patient education on LDL-C target achieving rate and statin adherence in patients with ACS in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients admitted to the hospital with a diagnosis of ACS including those for first consulting or with recurrence. The patient was prescribed atorvastatin (Lipitor®) by physicians in hospital;
- •The age of patient enrolled will be ≥18 years old;
- •The patient is able to understand and complete questionnaire.
- •The patients agree to accept follow-up visits, and willing to participate in patient education courses and sign informed consent form.
排除标准
- •The patient has contraindications to statins, such as active hepatic disease, patient has a history of intolerance or hypersensitivity to statins or has a history of prior rhabdomyolysis on a statin.
- •The patient who uses other statins except Lipitor® when discharged from the hospital;
- •Cardiac function class of the patient is class IV(NYHA);
- •The patient has a malignant tumor;
- •The patient has a severe arrhythmia.
结局指标
主要结局
LDL-C target achieving rate
时间窗: at Week 24 post-discharge
次要结局
- the proportions of patients with statin persistence(at Week 24 post-discharge)
- statin compliance(at Week 24 post-discharge)
- the relationship of LDL-C target achieving rate and statin compliance(at Week 24 post-discharge)
- the discontinuation reason of statin therapy(at Week 24 post-discharge)
- the difference of LDL-C control rate and statin compliance(at Week 24 post-discharge)
- LDL-C target achieving rate(at Week 12 post-discharge)
研究者
Junbo Ge
Professor
Shanghai Zhongshan Hospital