Angina, Unstable, Diabetes Mellitus
Conditions
Keywords
Neointima, Tomography, Optical Coherence, drug-eluting stents, Nicorandil
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.
Interventions
DRUGNicorandil
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
DRUGnicorandil placebo
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Sponsors
Zhang Ying Qian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal thickness (in μm) | 9 month | Neointimal thickness is defined as the distance between the stent strut and lumen surface. |
| Neointimal area | 9 month | Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of restenosis (in %) | 9 month | — |
| number of major adverse cardiovascular events | 9 month | — |
| number of in-stent neoatherosclerosis | 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 | The characteristics of neointimal hyperplasia will be assessed and classified into three patterns according to the neointimal signal intensity. |
| number of uncovered stent struts | 9 month | — |
| angiographic late lumen loss (in mm) | 9 month | Late lumen loss is the difference of baseline and follow-up minimal luminal diameters. |
Countries
China
Contacts
Primary ContactYing Qian Zhang, M.D.
Outcome results
None listed