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

December 7, 2018 updated by: Qian geng, Chinese PLA General Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100853
        • Recruiting
        • Chinese People's Liberation Army General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ezetimibe with simvastatin group
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
Drug: Ezetimibe with simvastatin
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
Active Comparator: Simvastatin group
simvastatin 40mg everyday for 12 months after PCI
Drug: Simvastatin
simvastatin 40mg everyday for 12 months after PCI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline coronary plaque volume percentage(PAV) at 12 months
Time Frame: 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
12 months after PCI

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline standardized coronary plaque volume(TAV) at 12 months
Time Frame: 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)
12 months after PCI
LDL-C
Time Frame: follow up in one year
Low density lipoprotein cholesterol (LDL-C)
follow up in one year
HDL-C
Time Frame: follow up in one year
High density lipoprotein cholesterol (HDL-C)
follow up in one year
TG
Time Frame: follow up in one year
Total triglyceride(TG)
follow up in one year
TC
Time Frame: follow up in one year
Total cholesterol (TC)
follow up in one year
Inflammation marker
Time Frame: follow up in one year
hs-CRP
follow up in one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese PLA General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yundai Chen, MD, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017FC-TSYS-3042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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