- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925079
Intensive Education on Lipid Management
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bingqing Huang
- Phone Number: 86-13816586495
- Email: huang.bingqing@zs-hospital.sh.cn
Study Locations
-
-
-
Beijing, China
- The Luhe Teaching Hospital of the Capital Medical University
-
Principal Investigator:
- Jincheng Guo, Professor
-
Shanghai, China, 200032
- Shanghai Zhongshan Hospital
-
Principal Investigator:
- Junbo Ge, Professor
-
-
Fujian
-
Fuzhou, Fujian, China
- Fujian Medical University Union Hospital
-
Principal Investigator:
- Ziliang Chen, Professor
-
-
Heilongjiang
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Harbin, Heilongjiang, China, 150001
- The 2nd Affiliated Hospital Of Harbin Medical University
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Principal Investigator:
- Bo Yu, Professor
-
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Shanxi
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Xi'an, Shanxi, China, 710061
- Xi'an Jiaotong University College of Medicine
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Principal Investigator:
- Zhuyi Yuan, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive Educational Group
The Intensive Educational Group will receive 5 visits, including 2 visits via phone contacts.
The expected dates for each visit will be stamped on the follow-up brochure for convenience.
Patient education in this group includes routine education at discharge; 4 educational brochures, a calendar with health tips, and follow-up brochure with medical expert letter sent to patients at the day for discharge (baseline); and educational short messages through message platform once a week.
Dosage and adjustment of statins, and concomitant medications in all the treated patients will be recorded.
|
Statin Treatment:The investigator will be suggested to increase the dose of atorvastatin according to guideline if a patient's LDL-C does not achieve target level. Patient education:
At discharge, patients will be given a brochure for future follow up. |
Sham Comparator: Control Group
The Control Group will receive 3 visits and receive care as per usual practice by the treating doctor and a follow-up brochure without medical expert letter.
Dosage and adjustment of statins, and concomitant medications in all the treated patients will be recorded.
Blood lipid panel (4 items), hepato-renal functions, and creatine kinase will be examined; while, Morisky 8-item questionnaire will be used to evaluate medication compliance at outpatient visits.
In addition, the occurrence of major cardiovascular events and AE/SAE will be collected during the study.
|
Statin Treatment:The recommended dosage of atorvastatin will be adjusted at the physician's discretion. Patient education:
At discharge, patients will be given a brochure for future follow up. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
LDL-C target achieving rate
Time Frame: at Week 24 post-discharge
|
at Week 24 post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LDL-C target achieving rate
Time Frame: at Week 12 post-discharge
|
at Week 12 post-discharge
|
|
the proportions of patients with statin persistence
Time Frame: at Week 12 post-discharge
|
at Week 12 post-discharge
|
|
the proportions of patients with statin persistence
Time Frame: at Week 24 post-discharge
|
at Week 24 post-discharge
|
|
statin compliance
Time Frame: at Week 12 post-discharge
|
at Week 12 post-discharge
|
|
statin compliance
Time Frame: at Week 24 post-discharge
|
at Week 24 post-discharge
|
|
the relationship of LDL-C target achieving rate and statin compliance
Time Frame: at Week 24 post-discharge
|
at Week 24 post-discharge
|
|
the discontinuation reason of statin therapy
Time Frame: at Week 24 post-discharge
|
at Week 24 post-discharge
|
|
the difference of LDL-C control rate and statin compliance
Time Frame: at Week 24 post-discharge
|
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
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the major adverse cardiovascular events
Time Frame: at 24 weeks follow up
|
at 24 weeks follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Junbo Ge, Professor, Fudan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACS-lipid-2013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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