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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00848562
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
Information provided by:
Toujinkai Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Congestive Heart Failure Drug: Nicorandil Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial
Study Start Date : January 2002
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Arm Intervention/treatment
Experimental: Nicorandil Drug: Nicorandil
Oral administration of nicorandil (15 mg/day)

Primary Outcome Measures :
  1. Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure) [ Time Frame: Jan 1, 2002 to Dec 31, 2006 ]

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Jan 1, 2002 to Dec 31, 2006 ]

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00848562

Toujinkai Hospital
Kyoto, Japan, 612-8026
Sponsors and Collaborators
Toujinkai Hospital Identifier: NCT00848562     History of Changes
Other Study ID Numbers: NICO-HDPCI-1
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

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
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs