The Effect of Simvastatin Combined With Ezetimibe in Patients With Stable Angina and Diabetes
NCT ID: NCT03771053
Last Updated: 2018-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2018-01-01
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ezetimibe with simvastatin group
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
Ezetimibe with simvastatin
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
Simvastatin group
simvastatin 40mg everyday for 12 months after PCI
Simvastatin
simvastatin 40mg everyday for 12 months after PCI
Interventions
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Ezetimibe with simvastatin
ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
Simvastatin
simvastatin 40mg everyday for 12 months after PCI
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Qian geng
associate chief physician
Principal Investigators
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Yundai Chen, MD
Role: STUDY_CHAIR
Chinese PLA General Hospital
Locations
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Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Geng Qian, MD
Role: primary
Yun-dai Chen, MD
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2017FC-TSYS-3042
Identifier Type: -
Identifier Source: org_study_id