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

NCT03771053 | Unknown DMC

• 1 other identifier: 2017FC-TSYS-3042
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

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

Outcome Measures

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

  12 months after PCI

Secondary Outcomes (6)

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

  12 months after PCI

• LDL-C

  follow up in one year

• HDL-C

  follow up in one year

• TG

  follow up in one year

• TC

  follow up in one year

Study Arms (2)

Ezetimibe with simvastatin group

EXPERIMENTAL

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

Drug: Ezetimibe with simvastatin

Simvastatin group

ACTIVE COMPARATOR

simvastatin 40mg everyday for 12 months after PCI

Drug: Simvastatin

Interventions

Ezetimibe with simvastatin DRUG

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

Ezetimibe with simvastatin group

Simvastatin DRUG

simvastatin 40mg everyday for 12 months after PCI

Simvastatin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 28927191 BACKGROUND

• 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.

  PMID: 20609967 BACKGROUND

• 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.

  PMID: 19675335 BACKGROUND

• 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.

  PMID: 26039521 BACKGROUND

• 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.

  PMID: 15389231 BACKGROUND

• 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.

  PMID: 18940534 BACKGROUND

• 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.

  PMID: 16787216 BACKGROUND

• 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.

  PMID: 16533939 BACKGROUND

• 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.

  PMID: 21446892 BACKGROUND

• 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.

  PMID: 22085316 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Atherosclerosis

Interventions

Ezetimibe; Simvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Yundai Chen, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Geng Qian, MD

CONTACT

13810914587; qiangeng9396@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2018
• Primary Completion: March 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

CN (1)