Clinical trial NCT03771053: The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
Atherosclerosis
Acute myocardial infarction
Coronary intervention
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline coronary plaque volume percentage(PAV) at 12 months
timeFrame: 12 months after PCI
Secondary outcomes:
measure: Change from Baseline standardized coronary plaque volume(TAV) at 12 months
timeFrame: 12 months after PCI
measure: LDL-C
timeFrame: follow up in one year
measure: HDL-C
timeFrame: follow up in one year
measure: TG
timeFrame: follow up in one year
measure: TC
timeFrame: follow up in one year
measure: Inflammation marker
timeFrame: follow up in one year
Other outcomes:
Locations:
city: Peking
country: China
facility: Chinese People's Liberation Army General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, MD
role: STUDY_CHAIR
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