Efficacy Study of Nicorandil on Neointima

Zhang Ying Qian

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus; Angina, Unstable

Treatments: Drug: nicorandil placebo; Drug: Nicorandil

Study type: Interventional

Funder types: Other

Identifiers

NCT02328521

S2014-099-03

S2014-120-01 (Other Identifier)

Details and patient eligibility

About

The investigators aim to investigate the effect of oral nicorandil on neointima after coronary drug-eluting stent implantation in patients with diabetic mellitus.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Nicorandil group

Experimental group

Description:

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.

Treatment:

Drug: Nicorandil

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: nicorandil placebo