Acute Coronary SyndromeNCT01925079
Intensive Education on Lipid Management
A study testing Intensive Education in people with Acute Coronary Syndrome, run by Junbo Ge at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Intensive Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,568 participants
- Where
- 5 sitesChina
- Study dates
- Aug 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
The Luhe Teaching Hospital of the Capital Medical University
Beijing
Jincheng Guo, Professor
Fujian Medical University Union Hospital
Fuzhou, Fujian
Ziliang Chen, Professor
The 2nd affiliated hospital of harbin medical university
Harbin, Heilongjiang, 150001
Bo Yu, Professor
Shanghai Zhongshan Hospital
Shanghai, 200032
Junbo Ge, Professor
Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, 710061
Zhuyi Yuan, Professor
About this study
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Intensive Education, Control
- Keywords
- acute coronary syndrome, statins, LDL-C, intensive education
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive EducationBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Educational Group | Experimental | 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. Receives: Behavioral: Intensive Education |
| Control Group | Sham comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C target achieving rate
Measured: at Week 24 post-discharge
Secondary outcomes (8)
LDL-C target achieving rate
Measured: at Week 12 post-discharge
the proportions of patients with statin persistence
Measured: at Week 12 post-discharge
the proportions of patients with statin persistence
Measured: at Week 24 post-discharge
statin compliance
Measured: at Week 12 post-discharge
statin compliance
Measured: at Week 24 post-discharge
the relationship of LDL-C target achieving rate and statin compliance
Measured: at Week 24 post-discharge
the discontinuation reason of statin therapy
Measured: at Week 24 post-discharge
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.
Measured: at Week 24 post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,568 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junbo Ge
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University, The Second Affiliated Hospital of Harbin Medical University, Xi'an Jiaotong University, The Luhe Teaching Hospital of the Capital Medical University
- Responsible party
- Sponsor-investigator, Junbo Ge, Shanghai Zhongshan Hospital
- Investigators
- Junbo Ge, Professor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925079
- Sponsor's protocol ID
- ACS-lipid-2013
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized and Controlled Study About the Impact of Intensive Education on Lipid Management in Patients With Acute Coronary Syndrome in China
- ClinicalTrials.gov ID
- NCT01925079
- Acronym / sponsor ID
- ACS-lipid-2013
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, statins, LDL-C, intensive education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,568 participants (estimated)
- Lead sponsor
- Junbo GeUniversity, hospital or other
- Collaborators
- Fujian Medical University, The Second Affiliated Hospital of Harbin Medical University, Xi'an Jiaotong University, The Luhe Teaching Hospital of the Capital Medical University
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Educational Group | Experimental | Behavioral: Intensive EducationThe 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. |
| Control Group | Sham comparator | Other: ControlThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive EducationStatin 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: 1. Routine education at discharge. 2. 4 education brochures will be delivered to patients. 3. Calendar with healthy tips will be delivered to patients before discharge. 4. A follow-up brochure with medical expert letter. 5. A total of 24 specific short messages for ACS will be developed and sent to patients (one short message per week). 6. Telephone follow ups will be performed according to a standard communication document. At discharge, patients will be given a brochure for future follow up. | Behavioural | Intensive Educational Group |
| ControlStatin Treatment：The recommended dosage of atorvastatin will be adjusted at the physician's discretion. Patient education: 1. Routine education at discharge. 2. A follow-up brochure without medical expert letter. At discharge, patients will be given a brochure for future follow up. | Other | Control Group |
Primary outcome
LDL-C target achieving rate
Time frame: at Week 24 post-discharge
8 secondary outcomes
LDL-C target achieving rate
Time frame: at Week 12 post-discharge
the proportions of patients with statin persistence
Time frame: at Week 12 post-discharge
the proportions of patients with statin persistence
Time frame: at Week 24 post-discharge
statin compliance
Time frame: at Week 12 post-discharge
statin compliance
Time frame: at Week 24 post-discharge
the relationship of LDL-C target achieving rate and statin compliance
Time frame: at Week 24 post-discharge
the discontinuation reason of statin therapy
Time frame: at Week 24 post-discharge
the difference of LDL-C control rate and statin compliance
Time frame: at Week 24 post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge, Professor principal investigator
Fudan University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Education in people with Acute Coronary Syndrome, run by Junbo Ge at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingqing Huang (86-13816586495, huang.bingqing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C target achieving rate (time frame: at Week 24 post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.