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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03771053
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Information provided by (Responsible Party):
Qian geng, 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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Drug: Ezetimibe with simvastatin Drug: Simvastatin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

  2. LDL-C [ Time Frame: follow up in one year ]
    Low density lipoprotein cholesterol (LDL-C)

  3. HDL-C [ Time Frame: follow up in one year ]
    High density lipoprotein cholesterol (HDL-C)

  4. TG [ Time Frame: follow up in one year ]
    Total triglyceride(TG)

  5. TC [ Time Frame: follow up in one year ]
    Total cholesterol (TC)

  6. Inflammation marker [ Time Frame: follow up in one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03771053

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Contact: Geng Qian, MD 13810914587

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China, Beijing
Chinese People's Liberation Army General Hospital Recruiting
Peking, Beijing, China, 100853
Contact: Geng Qian, MD    086-01055499312   
Contact: Yun-dai Chen, MD    086-01055499309   
Sponsors and Collaborators
Chinese PLA General Hospital
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Study Chair: Yundai Chen, MD Chinese PLA General Hospital

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Responsible Party: Qian geng, associate chief physician, Chinese PLA General Hospital Identifier: NCT03771053    
Other Study ID Numbers: 2017FC-TSYS-3042
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qian geng, Chinese PLA General Hospital:
Coronary heart disease
Acute myocardial infarction
Coronary intervention
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina, Stable
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors