Clinical trial NCT02328521: Efficacy Study of Nicorandil on Neointima
Official title: Efficacy Study of Nicorandil on Neointima After Coronary Drug-eluting Stent Implantation in Patients With Diabetic Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Angina, Unstable
Diabetes Mellitus
Keywords: Neointima
Tomography, Optical Coherence
drug-eluting stents
Nicorandil
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate the effect of oral nicorandil on neointima after coronary drug-eluting stent implantation in patients with diabetic mellitus.

Detailed description: In the era of bare metal stent (BMS), the restenosis rate was about 25%. The introduction of drug-eluting stent (DES) reduces restenosis rate to 4%-10%. Neointimal hyperplasia and restenosis remain to be problems after DES implantation. Besides, DES causes an increase in uncovered struts, late stent thrombosis, neoatherosclerosis, and heterogeneous neointima. Diabetes mellitus (DM) results in increased risk for atherosclerosis, in-stent restenosis, neoatherosclerosis and late-stent thrombosis. Nicorandil, a hybrid of adenosine triphosphate-sensitive potassium (K-ATP) channel opener and nitrates, has been shown to reduce target vessel revascularization after stent implantation, target lesion revascularization after rotational atherectomy, and restenosis in patients undergoing percutaneous coronary intervention (PCI). Intracoronary optical coherence tomography(OCT) has emerged as a high-resolution imaging method for analysis of neointima that grows over the stent. We aim to examine the effect of nicorandil on the neointima after coronary DES implantation in patients with unstable angina and DM.

Eligibility criteria: Inclusion Criteria:

* unstable angina with diabetes mellitus and is not given glibenclamide
* have clinical indication of percutaneous coronary intervention
* de novo severe stenosis in a native coronary artery
* lesion suitable for stent and optical coherence tomography examination
* reference vessel size between 2.5 and 4.0mm
* drug-eluting stent implantation only

Exclusion Criteria:

* acute myocardial infarction within 2 weeks before percutaneous coronary intervention
* contraindications to treatment with nicorandil (allergy, glaucoma, digestive ulcer, is currently taking phosphodiesterase-5 inhibitor)
* bypass restenosis
* PCI history
* hypotension
* intolerance of platelet inhibitors and statins
* impaired liver function
* renal insufficiency requiring hemodialysis
* pregnancy
* connective tissue disease
* life expectancy ≤ 12 months
* left main coronary artery disease
* bypass graft lesion and lesions unsuitable for OCT
* unwillingness or inability to provide informed consent

Primary outcomes:
measure: Neointimal thickness (in μm)
timeFrame: 9 month
measure: Neointimal area
timeFrame: 9 month
Secondary outcomes:
measure: number of uncovered stent struts
timeFrame: 9 month
measure: percent of uncovered stent struts
timeFrame: 9 month
measure: characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)
timeFrame: 9 month
measure: number of in-stent neoatherosclerosis
timeFrame: 9 month
measure: angiographic late lumen loss (in mm)
timeFrame: 9 month
measure: rate of restenosis (in %)
timeFrame: 9 month
measure: number of major adverse cardiovascular events
timeFrame: 9 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yundai Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Shehata M. Cardioprotective effects of oral nicorandil use in diabetic patients undergoing elective percutaneous coronary intervention. J Interv Cardiol. 2014 Oct;27(5):472-81. doi: 10.1111/joic.12142. Epub 2014 Aug 30.
citation: Nagoshi R, Shinke T, Otake H, Shite J, Matsumoto D, Kawamori H, Nakagawa M, Kozuki A, Hariki H, Inoue T, Ohsue T, Taniguchi Y, Iwasaki M, Nishio R, Hiranuma N, Konishi A, Kinutani H, Miyoshi N, Takaya T, Yamada S, Yasaka Y, Hayashi T, Yokoyama M, Kato H, Kadotani M, Ohnishi Y, Hirata K. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents. Circ J. 2013;77(3):652-60. doi: 10.1253/circj.cj-12-0610. Epub 2012 Dec 21.
citation: Tian F, Chen Y, Liu H, Zhang T, Guo J, Jin Q. Assessment of characteristics of neointimal hyperplasia after drug-eluting stent implantation in patients with diabetes mellitus: an optical coherence tomography analysis. Cardiology. 2014;128(1):34-40. doi: 10.1159/000357612. Epub 2014 Feb 7.
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