Clinical Trial: Efficacy Study of Nicorandil on Neointima

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy Study of Nicorandil on Neointima After Coronary Drug-eluting Stent Implantation in Patients With Diabetic Mellitus

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 Summary: 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.
Sponsor: Zhang Ying Qian

Current Primary Outcome:

  • Neointimal thickness (in μm) [ Time Frame: 9 month ]
    Neointimal thickness is defined as the distance between the stent strut and lumen surface.
  • Neointimal area [ Time Frame: 9 month ]
    Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • number of uncovered stent struts [ Time Frame: 9 month ]
  • percent of uncovered stent struts [ Time Frame: 9 month ]
  • 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.
  • number of in-stent neoatherosclerosis [ Time Frame: 9 month ]
  • angiographic late lumen loss (in mm) [ Time Frame: 9 month ]
    Late lumen loss is the difference of baseline and follow-up minimal luminal diameters.
  • rate of restenosis (in %) [ Time Frame: 9 month ]
  • number of major adverse cardiovascular events [ Time Frame: 9 month ]


Original Secondary Outcome: Same as current

Information By: Chinese PLA General Hospital

Dates:
Date Received: December 24, 2014
Date Started: December 2014
Date Completion: July 2016
Last Updated: January 17, 2015
Last Verified: January 2015