Efficacy Study of Nicorandil on Neointima After Coronary Drug-eluting Stent Implantation in Patients With Diabetic Mellitus
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Zhang Ying Qian
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Neointimal thickness (in μm)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Nicorandil (Drug)
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.
Intervention: nicorandil placebo (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- percent of uncovered stent struts(9 month)
- rate of restenosis (in %)(9 month)
- characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)(9 month)
- number of major adverse cardiovascular events(9 month)
- number of uncovered stent struts(9 month)
- number of in-stent neoatherosclerosis(9 month)
- angiographic late lumen loss (in mm)(9 month)
Investigators
Zhang Ying Qian
M.D.
Chinese PLA General Hospital