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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
48 participants
INTERVENTIONAL
2014-12-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective Assessment of Efficacy and Safety of Drug Eluting Stents
NCT02313038
Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System
NCT05477940
Optical Coherence TomOgraphy Assessment of the Drug-Eluting Stent
NCT01012583
Cordimax China Post Market Surveillance
NCT03185221
Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
NCT04119986
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nicorandil group
Drug: Nicorandil (Chugai Pharmaceutical Co, Japan). The first dose is given 8h before selective percutaneous coronary intervention, 10mg, oral. After the percutaneous coronary intervention, nicorandil is given for 30 days, 5mg each time, 3 times daily oral.
Nicorandil
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
Control group
Drug: Nicorandil placebo (Sihuan Pharmaceutical Co, China). The first dose is given 8h before selective percutaneous coronary intervention, 2 tablets, oral. After the percutaneous coronary intervention, placebo is given for 30 days, 1 tablet each time, 3 times daily oral.
nicorandil placebo
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nicorandil
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
nicorandil placebo
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhang Ying Qian
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhang Ying Qian
M.D.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yundai Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X.
Horinaka S, Yabe A, Yagi H, Ishimitsu T, Yamazaki T, Suzuki S, Kohro T, Nagai R; JCAD Study Investigators. Effects of nicorandil on cardiovascular events in patients with coronary artery disease in the Japanese Coronary Artery Disease (JCAD) study. Circ J. 2010 Mar;74(3):503-9. doi: 10.1253/circj.cj-09-0649. Epub 2010 Jan 18.
Machecourt J, Danchin N, Lablanche JM, Fauvel JM, Bonnet JL, Marliere S, Foote A, Quesada JL, Eltchaninoff H, Vanzetto G; EVASTENT Investigators. Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry. J Am Coll Cardiol. 2007 Aug 7;50(6):501-8. doi: 10.1016/j.jacc.2007.04.051. Epub 2007 Jul 23.
Kawai Y, Hisamatsu K, Matsubara H, Dan K, Akagi S, Miyaji K, Munemasa M, Fujimoto Y, Kusano KF, Ohe T. Intravenous administration of nicorandil immediately before percutaneous coronary intervention can prevent slow coronary flow phenomenon. Eur Heart J. 2009 Apr;30(7):765-72. doi: 10.1093/eurheartj/ehp077. Epub 2009 Mar 10.
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.
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.
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.
Chen J, Zhou S, Jin J, Tian F, Han Y, Wang J, Liu J, Chen Y. Chronic treatment with trimetazidine after discharge reduces the incidence of restenosis in patients who received coronary stent implantation: a 1-year prospective follow-up study. Int J Cardiol. 2014 Jul 1;174(3):634-9. doi: 10.1016/j.ijcard.2014.04.168. Epub 2014 Apr 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S2014-120-01
Identifier Type: OTHER
Identifier Source: secondary_id
S2014-099-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.