Efficacy Study of Nicorandil on Neointima

Phase 4

• Conditions: Diabetes Mellitus; Angina, Unstable
• Interventions: Drug: nicorandil placebo; Drug: Nicorandil

• Registration Number: NCT02328521
• Lead Sponsor: Zhang Ying Qian

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-24
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-17
• Last Update Posted: 2015-01-21
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	nicorandil placebo	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.
Nicorandil group	Nicorandil	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China