Clinical trial NCT01925079: Intensive Education on Lipid Management
Official title: A Randomized and Controlled Study About the Impact of Intensive Education on Lipid Management in Patients With Acute Coronary Syndrome in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
statins
LDL-C
intensive education
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Medical University
name: The Second Affiliated Hospital of Harbin Medical University
name: Xi'an Jiaotong University
name: The Luhe Teaching Hospital of the Capital Medical University
First posted: 2013-08-19
Enrollment: 2568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. The age of patient enrolled will be ≥18 years old;
3. The patient is able to understand and complete questionnaire.
4. The patients agree to accept follow-up visits, and willing to participate in patient education courses and sign informed consent form.

Exclusion Criteria:

1. 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.
2. The patient who uses other statins except Lipitor® when discharged from the hospital;
3. Cardiac function class of the patient is class IV(NYHA);
4. The patient has a malignant tumor;
5. The patient has a severe arrhythmia.

Primary outcomes:
measure: LDL-C target achieving rate
timeFrame: at Week 24 post-discharge
Secondary outcomes:
measure: LDL-C target achieving rate
timeFrame: at Week 12 post-discharge
measure: the proportions of patients with statin persistence
timeFrame: at Week 12 post-discharge
measure: the proportions of patients with statin persistence
timeFrame: at Week 24 post-discharge
measure: statin compliance
timeFrame: at Week 12 post-discharge
measure: statin compliance
timeFrame: at Week 24 post-discharge
measure: the relationship of LDL-C target achieving rate and statin compliance
timeFrame: at Week 24 post-discharge
measure: the discontinuation reason of statin therapy
timeFrame: at Week 24 post-discharge
measure: the difference of LDL-C control rate and statin compliance
timeFrame: at Week 24 post-discharge
Other outcomes:
measure: the major adverse cardiovascular events
timeFrame: at 24 weeks follow up
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Harbin
country: China
facility: The 2nd affiliated hospital of harbin medical university
state: Heilongjiang
city: Xi'an
country: China
facility: Xi'an Jiaotong University College of Medicine
state: Shanxi
city: Beijing
country: China
facility: The Luhe Teaching Hospital of the Capital Medical University
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Fudan University
name: Junbo Ge, Professor
role: PRINCIPAL_INVESTIGATOR
References: