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

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Coronary Heart Disease

Treatments: Drug: Simvastatin; Drug: Ezetimibe with simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03771053

2017FC-TSYS-3042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

Ezetimibe with simvastatin group

Experimental group

Description:

ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI

Treatment:

Drug: Ezetimibe with simvastatin

Simvastatin group

Active Comparator group

Description:

simvastatin 40mg everyday for 12 months after PCI

Treatment:

Drug: Simvastatin