Efficacy Study of Nicorandil on Neointima

January 17, 2015 updated by: Zhang Ying Qian

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nicorandil group
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.
Drug: Nicorandil
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
Other Names:
  • Sigmart
Placebo Comparator: Control group
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.
Drug: nicorandil placebo
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Other Names:
  • no other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neointimal thickness (in μm)
Time Frame: 9 month
Neointimal thickness is defined as the distance between the stent strut and lumen surface.
9 month
Neointimal area
Time Frame: 9 month
Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.
9 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of uncovered stent struts
Time Frame: 9 month
9 month
percent of uncovered stent struts
Time Frame: 9 month
9 month
characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)
Time Frame: 9 month
The characteristics of neointimal hyperplasia will be assessed and classified into three patterns according to the neointimal signal intensity.
9 month
number of in-stent neoatherosclerosis
Time Frame: 9 month
9 month
angiographic late lumen loss (in mm)
Time Frame: 9 month
Late lumen loss is the difference of baseline and follow-up minimal luminal diameters.
9 month
rate of restenosis (in %)
Time Frame: 9 month
9 month
number of major adverse cardiovascular events
Time Frame: 9 month
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang Ying Qian

Investigators

  • Principal Investigator: Yundai Chen, M.D., Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

December 24, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 17, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2014-099-03
  • S2014-120-01 (Other Identifier: ChinaPLAGH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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