Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients

Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00848562

Enrollment

129

Registered

2009-02-20

Start date

2002-01-31

Completion date

2006-12-31

Last updated

2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Congestive Heart Failure

Keywords

sudden cardiac death

Brief summary

Survival after invasive coronary revascularization is worse in patients with chronic kidney disease than in those without it. The investigators aimed to examine whether oral administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive potassium channel opener, could improve the survival of end-stage renal disease patients with coronary artery disease by inhibiting cardiac death after coronary revascularization.

Interventions

DRUGNicorandil

Oral administration of nicorandil (15 mg/day)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hemodialysis patients with coronary artery disease who had undergone a successful first PCI with bare-metal stents between July 1, 2001 and December 31, 2003.

Exclusion criteria

* Subjects with moderate or worse cardiac valvular disease or old myocardial infarction at the point of first PCI.

Design outcomes

Primary

Measure	Time frame
Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure)	Jan 1, 2002 to Dec 31, 2006

Secondary

Measure	Time frame
All-cause mortality	Jan 1, 2002 to Dec 31, 2006

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026