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

This study has been completed.
Information provided by:
Toujinkai Hospital Identifier:
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

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.

Condition Intervention
Acute Myocardial Infarction
Congestive Heart Failure
Drug: Nicorandil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

Resource links provided by NLM:

Further study details as provided by Toujinkai Hospital:

Primary Outcome Measures:
  • Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure) [ Time Frame: Jan 1, 2002 to Dec 31, 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Jan 1, 2002 to Dec 31, 2006 ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: January 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicorandil Drug: Nicorandil
Oral administration of nicorandil (15 mg/day)


Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00848562

Toujinkai Hospital
Kyoto, Japan, 612-8026
Sponsors and Collaborators
Toujinkai Hospital
  More Information

No publications provided Identifier: NCT00848562     History of Changes
Other Study ID Numbers: NICO-HDPCI-1
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Toujinkai Hospital:
sudden cardiac death

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on April 17, 2014