Acute Coronary Syndrome Clinical Trial
Official title:
A Randomized and Controlled Study About the Impact of Intensive Education on Lipid Management in Patients With Acute Coronary Syndrome in China
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.
Status | Not yet recruiting |
Enrollment | 2568 |
Est. completion date | June 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The Luhe Teaching Hospital of the Capital Medical University | Beijing | |
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
China | The 2nd affiliated hospital of harbin medical university | Harbin | Heilongjiang |
China | Shanghai Zhongshan Hospital | Shanghai | |
China | Xi'an Jiaotong University College of Medicine | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Junbo Ge | Fujian Medical University, The Luhe Teaching Hospital of the Capital Medical University, The Second Affiliated Hospital of Harbin Medical University, Xi’an Jiaotong University College of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | the major adverse cardiovascular events | at 24 weeks follow up | Yes | |
Primary | LDL-C target achieving rate | at Week 24 post-discharge | No | |
Secondary | LDL-C target achieving rate | at Week 12 post-discharge | No | |
Secondary | the proportions of patients with statin persistence | at Week 12 post-discharge | No | |
Secondary | the proportions of patients with statin persistence | at Week 24 post-discharge | No | |
Secondary | statin compliance | at Week 12 post-discharge | No | |
Secondary | statin compliance | at Week 24 post-discharge | No | |
Secondary | the relationship of LDL-C target achieving rate and statin compliance | at Week 24 post-discharge | No | |
Secondary | the discontinuation reason of statin therapy | at Week 24 post-discharge | No | |
Secondary | the difference of LDL-C control rate and statin compliance | To find the difference of LDL-C control rate and statin compliance between pre-specified sub-groups: PCI or non-PCI/male or female/age (=65) or not/ having medical insurance or not/dyslipidemia history or not /MI (myocardial infarction) or UA (unstable angina)/different risk level according to TIMI/ patients for first consulting or patients with recurrence/ have received statin in the last 3 months or not. | at Week 24 post-discharge | No |
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