NCT02328521

Efficacy Study of Nicorandil on Neointima

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Zhang Ying Qian · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angina, Unstable
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Nicorandil	Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
DRUG	nicorandil placebo	Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2014-12-31
• Last updated: 2015-01-21

Locations

1 site across 1 country: China