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Heart drug hopes to shield dialysis patients from deadly attacks

NCT ID NCT01475123

Disease control Sponsor: Kumamoto University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether the drug nicorandil can lower the risk of serious heart problems like heart attacks and strokes in people with coronary artery disease who are on kidney dialysis. Researchers are giving 15 mg of nicorandil daily to 268 participants and tracking heart-related events over time. The goal is to see if this drug offers extra protection for this high-risk group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nicorandil
What this could lead to
If it works, this could point toward a way to prevent heart attacks and strokes in people with kidney disease who are on dialysis.
What could go wrong
This is a relatively small, single-country trial, so results may not apply to everyone. Nicorandil may not reduce heart events as hoped, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

268 people

The number who actually took part.

Start date

Jun 2008

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease coronary artery disorder end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease End-stage renal disease

Contacts and locations

Locations

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

    Kumamoto, 860-8556, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.