Efficacy Study of Nicorandil on Neointima

NCT02328521 | Unknown Phase 4 DMC

• 2 other identifiers: S2014-099-03S2014-120-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina, Unstable; Diabetes Mellitus

Keywords

Neointima; Tomography, Optical Coherence; drug-eluting stents; Nicorandil

Outcome Measures

Primary Outcomes (2)

• Neointimal thickness (in μm)

  Neointimal thickness is defined as the distance between the stent strut and lumen surface.

  9 month

• Neointimal area

  Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.

  9 month

Secondary Outcomes (7)

• number of uncovered stent struts

  9 month

• percent of uncovered stent struts

  9 month

• characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)

  9 month

• number of in-stent neoatherosclerosis

  9 month

• angiographic late lumen loss (in mm)

  9 month

Study Arms (2)

Nicorandil group

EXPERIMENTAL

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.

Drug: Nicorandil

Control group

PLACEBO COMPARATOR

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.

Drug: nicorandil placebo

Interventions

Nicorandil DRUG

Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.

Also known as: Sigmart

Nicorandil group

nicorandil placebo DRUG

Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.

Also known as: no other names

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhang Ying Qian: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (8)

• 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.

  PMID: 11965271 BACKGROUND

• 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.

  PMID: 20081320 BACKGROUND

• 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.

  PMID: 17678732 BACKGROUND

• 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.

  PMID: 19276198 BACKGROUND

• 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.

  PMID: 25174952 BACKGROUND

• 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.

  PMID: 23257388 BACKGROUND

• 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.

  PMID: 24514877 BACKGROUND

• 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.

  PMID: 24809921 BACKGROUND

MeSH Terms

Conditions

Angina, Unstable; Diabetes Mellitus; Neointima

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yundai Chen, M.D.

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Qian Zhang, M.D.

CONTACT

86-15652505966; niniya731@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: December 31, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

CN (1)