Back to resultsNicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients
Primary Purpose
Acute Myocardial Infarction, Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Nicorandil
Sponsored by
About this trial
This is an interventional prevention trial for Acute Myocardial Infarction focused on measuring sudden cardiac death
Eligibility Criteria
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.
Sites / Locations
- Toujinkai Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nicorandil
Arm Description
Outcomes
Primary Outcome Measures
Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure)
Secondary Outcome Measures
All-cause mortality
Full Information
NCT ID
NCT00848562
First Posted
February 19, 2009
Last Updated
February 19, 2009
Sponsor
Toujinkai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00848562
Brief Title
Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients
Official Title
Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Toujinkai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Congestive Heart Failure
Keywords
sudden cardiac death
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicorandil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Intervention Description
Oral administration of nicorandil (15 mg/day)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
All-cause mortality
Time Frame
Jan 1, 2002 to Dec 31, 2006
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Toujinkai Hospital
City
Kyoto
ZIP/Postal Code
612-8026
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients
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