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Efficacy Study of Nicorandil on Neointima

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ClinicalTrials.gov Identifier: NCT02328521
Recruitment Status : Unknown
Verified January 2015 by Zhang Ying Qian, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : December 31, 2014
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Zhang Ying Qian, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Angina, Unstable Diabetes Mellitus Drug: Nicorandil Drug: nicorandil placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy Study of Nicorandil on Neointima After Coronary Drug-eluting Stent Implantation in Patients With Diabetic Mellitus
Study Start Date : December 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: 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.
Drug: Nicorandil
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
Other Name: Sigmart

Placebo Comparator: 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.
Drug: nicorandil placebo
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Other Name: no other names




Primary Outcome Measures :
  1. Neointimal thickness (in μm) [ Time Frame: 9 month ]
    Neointimal thickness is defined as the distance between the stent strut and lumen surface.

  2. Neointimal area [ Time Frame: 9 month ]
    Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.


Secondary Outcome Measures :
  1. number of uncovered stent struts [ Time Frame: 9 month ]
  2. percent of uncovered stent struts [ Time Frame: 9 month ]
  3. characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima) [ Time Frame: 9 month ]
    The characteristics of neointimal hyperplasia will be assessed and classified into three patterns according to the neointimal signal intensity.

  4. number of in-stent neoatherosclerosis [ Time Frame: 9 month ]
  5. angiographic late lumen loss (in mm) [ Time Frame: 9 month ]
    Late lumen loss is the difference of baseline and follow-up minimal luminal diameters.

  6. rate of restenosis (in %) [ Time Frame: 9 month ]
  7. number of major adverse cardiovascular events [ Time Frame: 9 month ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328521


Contacts
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Contact: Ying Qian Zhang, M.D. 86-15652505966 niniya731@163.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Yundai Chen, M.D.    86-010-55499309    cyundai@medmail.com.cn   
Sponsors and Collaborators
Zhang Ying Qian
Investigators
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Principal Investigator: Yundai Chen, M.D. Chinese PLA General Hospital
Publications:

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Responsible Party: Zhang Ying Qian, M.D., Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02328521    
Other Study ID Numbers: S2014-099-03
S2014-120-01 ( Other Identifier: ChinaPLAGH )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Zhang Ying Qian, Chinese PLA General Hospital:
Neointima
Tomography, Optical Coherence
drug-eluting stents
Nicorandil
Additional relevant MeSH terms:
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Angina, Unstable
Neointima
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Pathologic Processes
Nicorandil
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs