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

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Ezetimibe with simvastatin

Simvastatin

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary heart disease, Atherosclerosis, Acute myocardial infarction, Coronary intervention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Chinese People's Liberation Army General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ezetimibe with simvastatin group

Simvastatin group

Arm Description

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

simvastatin 40mg everyday for 12 months after PCI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

LDL-C

Low density lipoprotein cholesterol (LDL-C)

HDL-C

High density lipoprotein cholesterol (HDL-C)

Total triglyceride(TG)

Total cholesterol (TC)

Inflammation marker

hs-CRP

Full Information

NCT ID

NCT03771053

First Posted

December 4, 2018

Last Updated

December 7, 2018

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03771053

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

March 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

Coronary heart disease, Atherosclerosis, Acute myocardial infarction, Coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ezetimibe with simvastatin group

Arm Type

Experimental

Arm Description

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

Arm Title

Simvastatin group

Arm Type

Active Comparator

Arm Description

simvastatin 40mg everyday for 12 months after PCI

Intervention Type

Drug

Intervention Name(s)

Ezetimibe with simvastatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

simvastatin 40mg everyday for 12 months after PCI

Primary Outcome Measure Information:

Title

Change from Baseline coronary plaque volume percentage(PAV) at 12 months

Description

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

Time Frame

12 months after PCI

Secondary Outcome Measure Information:

Title

Change from Baseline standardized coronary plaque volume(TAV) at 12 months

Description

Time Frame

12 months after PCI

Title

LDL-C

Description

Low density lipoprotein cholesterol (LDL-C)

Time Frame

follow up in one year

Title

HDL-C

Description

High density lipoprotein cholesterol (HDL-C)

Time Frame

follow up in one year

Title

Description

Total triglyceride(TG)

Time Frame

follow up in one year

Title

Description

Total cholesterol (TC)

Time Frame

follow up in one year

Title

Inflammation marker

Description

hs-CRP

Time Frame

follow up in one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Geng Qian, MD

Phone

13810914587

qiangeng9396@263.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yundai Chen, MD

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Chinese People's Liberation Army General Hospital

City

Peking

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Geng Qian, MD

Phone

086-01055499312

qiangeng9396@263.net

First Name & Middle Initial & Last Name & Degree

Yun-dai Chen, MD

Phone

086-01055499309

cyundai@126.com

12. IPD Sharing Statement

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

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