Intensive Education on Lipid Management

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01925079
• Other study ID #: ACS-lipid-2013
• Status: Not yet recruiting
• Phase: N/A
• First received: August 15, 2013
• Last updated: August 18, 2013
• Start date: August 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: Shanghai Zhongshan Hospital
• Contact: Bingqing Huang
• Phone: 86-13816586495
• Email: huang.bingqing[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Behavioral:
• Intensive Education
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: Routine education at discharge. 4 education brochures will be delivered to patients. Calendar with healthy tips will be delivered to patients before discharge. A follow-up brochure with medical expert letter. A total of 24 specific short messages for ACS will be developed and sent to patients (one short message per week). Telephone follow ups will be performed according to a standard communication document. At discharge, patients will be given a brochure for future follow up.

Other:
• Control
Statin Treatment:The recommended dosage of atorvastatin will be adjusted at the physician's discretion. Patient education: Routine education at discharge. A follow-up brochure without medical expert letter. At discharge, patients will be given a brochure for future follow up.

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

China, 

Outcome

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