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Angina, UnstablePhase 4NCT02328521

Efficacy Study of Nicorandil on Neointima

A Phase 4 study testing Nicorandil in people with Angina, Unstable and Diabetes Mellitus, run by Zhang Ying Qian at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Angina, Unstable, Diabetes Mellitus
What is being tested?
Nicorandil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteChina
Study dates
Dec 2014to Jul 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

Ying Qian Zhang, M.D. contact

86-15652505966

niniya731@163.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Yundai Chen, M.D., 86-010-55499309, cyundai@medmail.com.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Nicorandil, nicorandil placebo
Keywords
Neointima, Tomography, Optical Coherence, drug-eluting stents, Nicorandil
Medical subject headings
Angina, Unstable, Diabetes Mellitus, Neointima

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NicorandilDrug

    Also called Sigmart

    Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.

  • nicorandil placeboDrug

    Also called no other names

    Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.

Study groups in NCT02328521
Study groupRoleWhat they receive
Nicorandil groupExperimentalDrug: 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.
Receives: Drug: Nicorandil
Control groupPlacebo comparatorDrug: 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.
Receives: Drug: nicorandil placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neointimal thickness (in μm)

    Neointimal thickness is defined as the distance between the stent strut and lumen surface.

    Measured: 9 month

  2. Neointimal area

    Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.

    Measured: 9 month

Secondary outcomes (7)

  1. number of uncovered stent struts

    Measured: 9 month

  2. percent of uncovered stent struts

    Measured: 9 month

  3. characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima)

    The characteristics of neointimal hyperplasia will be assessed and classified into three patterns according to the neointimal signal intensity.

    Measured: 9 month

  4. number of in-stent neoatherosclerosis

    Measured: 9 month

  5. angiographic late lumen loss (in mm)

    Late lumen loss is the difference of baseline and follow-up minimal luminal diameters.

    Measured: 9 month

  6. rate of restenosis (in %)

    Measured: 9 month

  7. number of major adverse cardiovascular events

    Measured: 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionJun 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328521
Sponsor's protocol ID
S2014-099-03
Other IDs
S2014-120-01
Status last verified
Jan 2015
First submitted
24 Dec 2014
Last updated
21 Jan 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • IONA Study Group. Effect of nicorandil on coronary events in patients with stable angina: the Impact Of Nicorandil in Angina (IONA) randomised trial. Lancet. 2002 Apr 13;359(9314):1269-75. doi: 10.1016/S0140-6736(02)08265-X.

    PubMed 11965271

  • Horinaka S, Yabe A, Yagi H, Ishimitsu T, Yamazaki T, Suzuki S, Kohro T, Nagai R; JCAD Study Investigators. Effects of nicorandil on cardiovascular events in patients with coronary artery disease in the Japanese Coronary Artery Disease (JCAD) study. Circ J. 2010 Mar;74(3):503-9. doi: 10.1253/circj.cj-09-0649. Epub 2010 Jan 18.

    PubMed 20081320

  • Machecourt J, Danchin N, Lablanche JM, Fauvel JM, Bonnet JL, Marliere S, Foote A, Quesada JL, Eltchaninoff H, Vanzetto G; EVASTENT Investigators. Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry. J Am Coll Cardiol. 2007 Aug 7;50(6):501-8. doi: 10.1016/j.jacc.2007.04.051. Epub 2007 Jul 23.

    PubMed 17678732

  • Kawai Y, Hisamatsu K, Matsubara H, Dan K, Akagi S, Miyaji K, Munemasa M, Fujimoto Y, Kusano KF, Ohe T. Intravenous administration of nicorandil immediately before percutaneous coronary intervention can prevent slow coronary flow phenomenon. Eur Heart J. 2009 Apr;30(7):765-72. doi: 10.1093/eurheartj/ehp077. Epub 2009 Mar 10.

    PubMed 19276198

  • Shehata M. Cardioprotective effects of oral nicorandil use in diabetic patients undergoing elective percutaneous coronary intervention. J Interv Cardiol. 2014 Oct;27(5):472-81. doi: 10.1111/joic.12142. Epub 2014 Aug 30.

    PubMed 25174952

  • Nagoshi R, Shinke T, Otake H, Shite J, Matsumoto D, Kawamori H, Nakagawa M, Kozuki A, Hariki H, Inoue T, Ohsue T, Taniguchi Y, Iwasaki M, Nishio R, Hiranuma N, Konishi A, Kinutani H, Miyoshi N, Takaya T, Yamada S, Yasaka Y, Hayashi T, Yokoyama M, Kato H, Kadotani M, Ohnishi Y, Hirata K. Qualitative and quantitative assessment of stent restenosis by optical coherence tomography: comparison between drug-eluting and bare-metal stents. Circ J. 2013;77(3):652-60. doi: 10.1253/circj.cj-12-0610. Epub 2012 Dec 21.

    PubMed 23257388

  • Tian F, Chen Y, Liu H, Zhang T, Guo J, Jin Q. Assessment of characteristics of neointimal hyperplasia after drug-eluting stent implantation in patients with diabetes mellitus: an optical coherence tomography analysis. Cardiology. 2014;128(1):34-40. doi: 10.1159/000357612. Epub 2014 Feb 7.

    PubMed 24514877

  • Chen J, Zhou S, Jin J, Tian F, Han Y, Wang J, Liu J, Chen Y. Chronic treatment with trimetazidine after discharge reduces the incidence of restenosis in patients who received coronary stent implantation: a 1-year prospective follow-up study. Int J Cardiol. 2014 Jul 1;174(3):634-9. doi: 10.1016/j.ijcard.2014.04.168. Epub 2014 Apr 21.

    PubMed 24809921

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nicorandil in people with Angina, Unstable and Diabetes Mellitus, run by Zhang Ying Qian at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Qian Zhang, M.D. (86-15652505966, niniya731@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neointimal thickness (in μm) (time frame: 9 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328521, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.

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