The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes

Study Overview
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Brief Summary
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In this study, simvastatin combined with Ezeimebum was used to enhance lipid reduction, and IVUS was used to evaluate the volume and composition of coronary plaque before and after treatment. The aim is to evaluate the overall intervention effect of Ezeimebum on stable angina pectoris with diabetes mellitus on the basis of statins.

Detailed Description
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This study was conducted in patients with stable angina pectoris complicated with diabetes mellitus in Chinese PLA General Hospital and coronary arteriography confirmed as critical lesion of coronary artery. The patients were randomly divided into two groups: ezeimebum combined with simvastatin group and simvastatin group. The patients of the former group were given ezeimebum 10mg combined with simvastatin 40mg for 12 months while the patients of the latter group were given simvastatin 40mg for 12 months. Assessed coronary atherosclerotic plaque volume percentage (PAV) and standardized total atherosclerotic plaque volume (TAV) by intravascular ultrasound (IVUS) at the time of entry and out of the group after 12 months. The changes of PAV level in both groups were taken as the main endpoints, and the changes of TAV levels in the two groups as the secondary endpoints. The changes of serum lipids and hypersensitive C-reactive protein levels were compared between the two groups before and after the treatment. Major cardiovascular events (non-fatal myocardial infarction, all-cause death, readmission to acute heart failure, and revascularization of recurrent angina pectoris) were followed up for 12 months.

Official Title
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Intravascular Ultrasound Evaluation of the Intervention Effect of Simvastatin Combined With Ezetimibe on Coronary Borderline Lesion in Patients With Stable Angina Pectoris and Diabetes Mellitus Compared With Simvastatin Alone

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: Ezetimibe with simvastatin
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 18-75 years consistent with the Chinese criteria for the diagnosis of chronic stable angina pectoris, stable angina pectoris symptoms in the last three months, and no more than CCS grade 3 of angina pectoris coronary angiography showed that the degree of coronary artery stenosis was 50% and 70% LDL-C standard: LDL-C > 80 mg/dL (2.08 mmol/L) The patients diagnosed with type 2 diabetes were currently using hypoglycemic drugs or insulin Sign the informed consent to join the group. Exclusion Criteria: Acute coronary syndromes such as myocardial infarction, unstable angina pectoris, variant angina pectoris, cardiac shock, chronic heart failure, malignant arrhythmia, etc. Patients requiring stent implantation had been treated with intensive statins prior to admission (e.g. doses of Atto vastatin 40mg or resuvastatin 20mg) There were contraindications or statins for statin lowering lipids or statins, and there was a history of adverse reactions (liver injury, rash, myolysis, etc.) in the use of Ezeimebum, etc. Severe liver and kidney dysfunction, creatinine clearance < 30ml / min, acute pancreatitis, malignant tumor, etc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe with simvastatin group<br>ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI | Drug: Ezetimibe with simvastatin<br>* ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI<br>|
| Active Comparator: Simvastatin group<br>simvastatin 40mg everyday for 12 months after PCI | Drug: Simvastatin<br>* simvastatin 40mg everyday for 12 months after PCI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline coronary plaque volume percentage(PAV) at 12 months | PAV=∑（(ESA CSA-lumen CSA)/(ESA CSA)）x100, EEM CSA：cross-sectional area of outer elastic membrane boundary; lumen CSA: cross-sectional area of tube boundary | 12 months after PCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline standardized coronary plaque volume(TAV) at 12 months | TAV= (median number of images in ∑ (ESA CSA-lumen CSA) / retracement) x number of images (standardized according to the length of IVUS retracement, To ensure that each individual patient has the same weight) | 12 months after PCI | 
| LDL-C | Low density lipoprotein cholesterol (LDL-C) | follow up in one year | 
| HDL-C | High density lipoprotein cholesterol (HDL-C) | follow up in one year | 
| TG | Total triglyceride(TG) | follow up in one year | 
| TC | Total cholesterol (TC) | follow up in one year | 
| Inflammation marker | hs-CRP | follow up in one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary heart disease, Atherosclerosis, Acute myocardial infarction, Coronary intervention