Efficacy Study of Nicorandil on Neointima

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhang Ying Qian
• Treatments: Nicorandil

Criteria

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