The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes
- Conditions
- Coronary Heart Disease
- Interventions
- Registration Number
- NCT03771053
- Lead Sponsor
- Chinese PLA General Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ezetimibe with simvastatin group Ezetimibe with simvastatin ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI Simvastatin group Simvastatin simvastatin 40mg everyday for 12 months after PCI
- Primary Outcome Measures
Name Time Method Change from Baseline coronary plaque volume percentage(PAV) at 12 months 12 months after PCI 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
- Secondary Outcome Measures
Name Time Method TC follow up in one year Total cholesterol (TC)
LDL-C follow up in one year Low density lipoprotein cholesterol (LDL-C)
Change from Baseline standardized coronary plaque volume(TAV) at 12 months 12 months after PCI 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)
HDL-C follow up in one year High density lipoprotein cholesterol (HDL-C)
TG follow up in one year Total triglyceride(TG)
Inflammation marker follow up in one year hs-CRP
Trial Locations
- Locations (1)
Chinese People's Liberation Army General Hospital
🇨🇳Peking, Beijing, China