Coronary Artery Disease / Nicorandil / End Stage Renal Disease · Phase 4 Trial

Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil

ClinicalTrials.gov · September 3, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 4 trial registration examining nicorandil for cardiovascular event reduction in end-stage renal disease patients with coronary artery disease. No results are posted in this registry record; the study is active but not currently recruiting, and outcome data are not yet available to assess efficacy or safety.

What was studied

Phase 4, Interventional, Randomized, Parallel, Open label, Prevention purpose. Coronary Artery Disease, End Stage Renal Disease. Intervention: Nicorandil. Compared with: Non-nicorandil — No Intervention. n = 268. 1 site: Japan.

Key findings

Safety

Efficacy, safety, or harm cannot be assessed from this registry entry alone.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record with no reported results; the study is active but not yet recruiting completion, precluding evidence of efficacy.

Study design

As stated by the source record.

MethodsPrimary outcome measure: The primary endpoint is composite of :1) cardiovascular death 2)sudden cardiac death 3)nonfatal myocardial infarction 4)Hospitalization for recurrent symptomatic myocardial ischem… (assessed at 2 years)

DesignPhase 4, Interventional, Randomized, Parallel, Open label, Prevention purpose

PopulationCoronary Artery Disease, End Stage Renal Disease

Sample size268

InterventionNicorandil

ComparatorNon-nicorandil — No Intervention

Setting1 site: Japan

Reported figures

Quoted from the source exactly as published.

Planned enrollment268

PhasePhase 4

Primary endpointComposite of cardiovascular death, sudden cardiac death, nonfatal myocardial infarction, hospitalization for recurrent symptomatic myocardial ischemia, stroke at 2 years

Caveats

Registry record only; no results have been posted or published from this trial.
Study status is active but not recruiting; completion date and availability of final results are unknown.
No data on actual enrollment completion, participant characteristics, or outcome event rates.
Efficacy, safety, or harm cannot be assessed from this registry entry alone.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 4 prospective interventional study with composite cardiovascular endpoint; design is appropriate but results not yet reported.

Directness

strong

Directly addresses cardiovascular outcomes in target population: CAD patients on hemodialysis.

Consistency

insufficient

Registry record alone; no results available to assess consistency with other evidence.

Risk of bias

insufficient

No results or methods detail reported; cannot assess blinding, allocation concealment, or completion.

Sample adequacy

moderate

Planned enrollment 268 participants is reasonable for composite endpoint; final enrolled number not confirmed.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT01475123). This is a study registration, not published results. Lead sponsor: Kumamoto University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 268 participants (ACTUAL). Conditions: Coronary Artery Disease, End Stage Renal Disease. Interventions: DRUG: Nicorandil. Primary outcome measures: 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Kumamoto UniversityNCT01475123Coronary Artery DiseaseNicorandilEnd Stage Renal Disease