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Status unknownNCT03771053Updated Dec 10, 2018

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

An interventional study of Ezetimibe with simvastatin and Simvastatin in Coronary Heart Disease, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-12-10.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2018, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • Coronary heart disease
  • Atherosclerosis
  • Acute myocardial infarction
  • Coronary intervention
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 240 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Ezetimibe with simvastatin group

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

    Drug: Ezetimibe with simvastatin

  • Active comparator
    Simvastatin group

    simvastatin 40mg everyday for 12 months after PCI

    Drug: Simvastatin

Interventions

  • DrugEzetimibe with simvastatin

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

  • DrugSimvastatin

    simvastatin 40mg everyday for 12 months after PCI

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months after PCI

Secondary outcomes

  1. 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)

    Time frame: 12 months after PCI

  2. LDL-C

    Low density lipoprotein cholesterol (LDL-C)

    Time frame: follow up in one year

  3. HDL-C

    High density lipoprotein cholesterol (HDL-C)

    Time frame: follow up in one year

  4. TG

    Total triglyceride(TG)

    Time frame: follow up in one year

  5. TC

    Total cholesterol (TC)

    Time frame: follow up in one year

  6. Inflammation marker

    hs-CRP

    Time frame: follow up in one year

07

Study locations

1 of 1 sites recruiting
  • Chinese People's Liberation Army General Hospital
    Peking, Beijing 100853, China
    Recruiting
08

References and documents

Publications

  • Zhang X, Khan AA, Haq EU, Rahim A, Hu D, Attia J, Oldmeadow C, Ma X, Ding R, Boyle AJ. Increasing mortality from ischaemic heart disease in China from 2004 to 2010: disproportionate rise in rural areas and elderly subjects. 438 million person-years follow-up. Eur Heart J Qual Care Clin Outcomes. 2017 Jan 1;3(1):47-52. doi: 10.1093/ehjqcco/qcw041. PubMed 28927191 ↗
  • Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9. Erratum In: Lancet. 2010 Sep 18;376(9745):958. Hillage, H L [corrected to Hillege, H L]. PubMed 20609967 ↗
  • Califf RM, Harrington RA, Blazing MA. Premature release of data from clinical trials of ezetimibe. N Engl J Med. 2009 Aug 13;361(7):712-7. doi: 10.1056/NEJMsr0900910. No abstract available. PubMed 19675335 ↗
  • Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3. PubMed 26039521 ↗
  • Stein E, Stender S, Mata P, Sager P, Ponsonnet D, Melani L, Lipka L, Suresh R, Maccubbin D, Veltri E; Ezetimibe Study Group. Achieving lipoprotein goals in patients at high risk with severe hypercholesterolemia: efficacy and safety of ezetimibe co-administered with atorvastatin. Am Heart J. 2004 Sep;148(3):447-55. doi: 10.1016/j.ahj.2004.03.052. PubMed 15389231 ↗
  • van der Graaf A, Cuffie-Jackson C, Vissers MN, Trip MD, Gagne C, Shi G, Veltri E, Avis HJ, Kastelein JJ. Efficacy and safety of coadministration of ezetimibe and simvastatin in adolescents with heterozygous familial hypercholesterolemia. J Am Coll Cardiol. 2008 Oct 21;52(17):1421-9. doi: 10.1016/j.jacc.2008.09.002. PubMed 18940534 ↗
  • Nicholls SJ, Sipahi I. Emerging role of intravascular ultrasound in the assessment of experimental anti-atherosclerotic therapies. Curr Med Chem. 2006;13(15):1727-34. doi: 10.2174/092986706777452498. PubMed 16787216 ↗
  • Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. doi: 10.1001/jama.295.13.jpc60002. Epub 2006 Mar 13. PubMed 16533939 ↗
  • Nicholls SJ, Borgman M, Nissen SE, Raichlen JS, Ballantyne C, Barter P, Chapman MJ, Erbel R, Libby P. Impact of statins on progression of atherosclerosis: rationale and design of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: effect of Rosuvastatin versus AtorvastatiN). Curr Med Res Opin. 2011 Jun;27(6):1119-29. doi: 10.1185/03007995.2011.570746. Epub 2011 Mar 30. PubMed 21446892 ↗
  • Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15. PubMed 22085316 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03771053
Lead sponsor
Chinese PLA General Hospital
Responsible party
Qian geng (associate chief physician, Chinese PLA General Hospital) — Principal investigator
First posted
Dec 10, 2018
Start date
Jan 1, 2018
Primary completion
Mar 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Dec 10, 2018

Study contacts

Geng Qian, MD
Contact
qiangeng9396@263.net
13810914587
Yundai Chen, MD
study chair · Chinese PLA General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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