## Protocol Section
### Identification Module
**NCT ID:** NCT01925079

**Brief Title:** 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

#### Organization Study ID Info
**ID:** ACS-lipid-2013
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Zhongshan Hospital
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2013-08-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-08-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2015-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-08

**Status Verified Date:** 2013-08

#### Study First Post Date
**Date:** 2013-08-19
**Type:** ESTIMATED
**Study First Submit Date:** 2013-08-15
**Study First Submit QC Date:** 2013-08-15
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fujian Medical University

**Class:** OTHER

**Name:** The Second Affiliated Hospital of Harbin Medical University

**Class:** OTHER

**Name:** Health Science Center of Xi'an Jiaotong University

**Class:** OTHER

**Name:** The Luhe Teaching Hospital of the Capital Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Junbo Ge

#### Responsible Party

**Investigator Affiliation:** Shanghai Zhongshan Hospital

**Investigator Full Name:** Junbo Ge

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Acute Coronary Syndrome

**Keywords:**

- acute coronary syndrome

- statins

- LDL-C

- intensive education

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 2568

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Intensive Education

**Label:** Intensive Educational Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Control

**Label:** Control Group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intensive Educational Group

**Description:** 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:

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.

**Name:** Intensive Education

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** Statin 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.

**Name:** Control

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Measure:** the major adverse cardiovascular events

**Time Frame:** at 24 weeks follow up

#### Primary Outcomes

**Measure:** LDL-C target achieving rate

**Time Frame:** at Week 24 post-discharge

#### Secondary Outcomes

**Measure:** LDL-C target achieving rate

**Time Frame:** at Week 12 post-discharge

**Measure:** the proportions of patients with statin persistence

**Time Frame:** at Week 12 post-discharge

**Measure:** the proportions of patients with statin persistence

**Time Frame:** at Week 24 post-discharge

**Measure:** statin compliance

**Time Frame:** at Week 12 post-discharge

**Measure:** statin compliance

**Time Frame:** at Week 24 post-discharge

**Measure:** the relationship of LDL-C target achieving rate and statin compliance

**Time Frame:** at Week 24 post-discharge

**Measure:** the discontinuation reason of statin therapy

**Time Frame:** at Week 24 post-discharge

**Description:** 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.

**Measure:** the difference of LDL-C control rate and statin compliance

**Time Frame:** at Week 24 post-discharge

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** huang.bingqing@zs-hospital.sh.cn

**Name:** Bingqing Huang

**Phone:** 86-13816586495

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Name:** Ziliang Chen, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Fujian Medical University Union Hospital

**State:** Fujian

**Location 2:**

**City:** Harbin

**Contacts:**

***Contact 1:***

- **Name:** Bo Yu, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** The 2nd affiliated hospital of harbin medical university

**State:** Heilongjiang

**Zip:** 150001

**Location 3:**

**City:** Xi'an

**Contacts:**

***Contact 1:***

- **Name:** Zhuyi Yuan, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Xi'an Jiaotong University College of Medicine

**State:** Shanxi

**Zip:** 710061

**Location 4:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Name:** Jincheng Guo, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** The Luhe Teaching Hospital of the Capital Medical University

**Location 5:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Junbo Ge, Professor

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shanghai Zhongshan Hospital

**Zip:** 200032

#### Overall Officials

**Official 1:**

**Affiliation:** Fudan University

**Name:** Junbo Ge, Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M27545

- Name: Acute Coronary Syndrome

- Relevance: HIGH

- As Found: Acute Coronary Syndrome

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000054058

- Term: Acute Coronary Syndrome

- ID: D000013577

- Term: Syndrome

### Intervention Browse Module - Browse Branches

- Abbrev: Lipd

- Name: Lipid Regulating Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M351

- Name: Atorvastatin

- Relevance: LOW

- As Found: Unknown

- ID: M21155

- Name: Hydroxymethylglutaryl-CoA Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: T385

- Name: Creatine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
