NCT01475123

Brief Summary

Nicorandil is potentially effective to prevent cardiovascular events in patients with coronary artery disease (CAD) receiving hemodialysis. The purpose of this study is to prospectively investigate whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with CAD on hemodialysis.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
268

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
14.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

November 16, 2011

Last Update Submit

September 11, 2025

Conditions

Coronary Artery DiseaseEnd Stage Renal Disease

Keywords

NicorandilRandomized control studyHemodialysisCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is composite of :1) cardiovascular death 2)sudden cardiac death 3)nonfatal myocardial infarction 4)Hospitalization for recurrent symptomatic myocardial ischemia 5)stroke

    2 years

Secondary Outcomes (5)

  • Total mortality

    2 years

  • revascularization therapy

    2 years

  • hospitalization for heart failure

    2 years

  • hospitalization for peripheral artery disease

    2 years

  • newly onset of atrial fibrillation

    2 years

Study Arms (2)

Nicorandil

ACTIVE COMPARATOR

Nicorandil was administered orally (15mg/day).

Drug: Nicorandil

Non-nicorandil

NO INTERVENTION

Nicorandil was not administered.

Interventions

NicorandilDRUG

15mg per day

Also known as: Sigmart
Nicorandil

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible patients are who meet the following criteria:
  • Patient with previously diagnosed coronary artery disease (significant coronary artery stenosis is defined as \> 75% narrowing of the artery lumen)
  • Patients who continued hemodialysis for more than one month

You may not qualify if:

  • Within one month after acute myocardial infarction
  • Within 3 months after coronary artery bypass graft (CABG)
  • Treatment with phosphodiesterase type 5 inhibitor
  • Candidates for carotid artery stenting
  • Severe disease requiring active medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University

Kumamoto, 860-8556, Japan

Location

Related Publications (1)

  • Ishii H, Toriyama T, Aoyama T, Takahashi H, Yamada S, Kasuga H, Ichimiya S, Kanashiro M, Mitsuhashi H, Maruyama S, Matsuo S, Naruse K, Matsubara T, Murohara T. Efficacy of oral nicorandil in patients with end-stage renal disease: a retrospective chart review after coronary angioplasty in Japanese patients receiving hemodialysis. Clin Ther. 2007 Jan;29(1):110-22. doi: 10.1016/j.clinthera.2007.12.020.

    PMID: 17379051BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseKidney Failure, Chronic

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitratesOrganic ChemicalsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Hisao Ogawa, MD, PhD

    Kumamoto University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 21, 2011

Study Start

June 1, 2008

Primary Completion

June 1, 2011

Study Completion

March 1, 2026

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

JP(1)