Coronary Heart Disease Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Chinese People's Liberation Army General Hospital | Peking | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
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Nicholls SJ, Sipahi I. Emerging role of intravascular ultrasound in the assessment of experimental anti-atherosclerotic therapies. Curr Med Chem. 2006;13(15):1727-34. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | LDL-C | Low density lipoprotein cholesterol (LDL-C) | follow up in one year | |
Secondary | HDL-C | High density lipoprotein cholesterol (HDL-C) | follow up in one year | |
Secondary | TG | Total triglyceride(TG) | follow up in one year | |
Secondary | TC | Total cholesterol (TC) | follow up in one year | |
Secondary | Inflammation marker | hs-CRP | follow up in one year |
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