Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
Primary Purpose
Coronary Artery Disease, End Stage Renal Disease
Status
Active
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Nicorandil
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Nicorandil, Randomized control study, Hemodialysis, Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Nicorandil
Non-nicorandil
Arm Description
Nicorandil was administered orally (15mg/day).
Nicorandil was not administered.
Outcomes
Primary Outcome Measures
The primary endpoint is composite of :1) cardiovascular death 2)sudden cardiac death 3)nonfatal myocardial infarction 4)Hospitalization for recurrent symptomatic myocardial ischemia 5)stroke
Secondary Outcome Measures
Total mortality
revascularization therapy
hospitalization for heart failure
hospitalization for peripheral artery disease
newly onset of atrial fibrillation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01475123
Brief Title
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
Official Title
Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kumamoto University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nicorandil is potentially effective to prevent cardiovascular events in patients with coronary artery disease (CAD) receiving hemodialysis. The purpose of this study is to prospectively investigate whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with CAD on hemodialysis.
Detailed Description
Patients on hemodialysis for end-stage renal disease are at high risk for death from ischemic heart disease. It was reported that nicorandil, a hybrid compound on adenosine triphosphate-sensitive potassium channel opener and nitric oxide door, was potentially effective to prevent cardiovascular events in patients with CAD receiving hemodialysis. Therefore, investigators prospectively examine whether nicorandil is effective in reducing the incidence of cardiovascular events in patients with CAD on hemodialysis.
The primary endpoint is a composite of cardiovascular death, sudden cardiac death, nonfatal myocardial infarction, hospitalization for recurrent symptomatic myocardial ischemia and stroke. The secondary endpoints are total mortality, revascularization therapy, hospitalization for heart failure, hospitalization for peripheral artery disease and newly onset of atrial fibrillation.
Patient population that needs to prove the hypothesis is estimate to be 300 cases in total (150 cases in each group). Investigators set the parameters which are need to calculate the number of study patients as follows; drop out rate 10%, an event rate of the primary end point for two years 50%, a risk reduction rate brought by nicorandil 60%, a statistical power 80% and two-sided significant level 0.05. Investigators referred the event rate and the risk reduction rate from the previous study by Ishi H et al. In this study, event rate of the primary end point for two years was 50% and the risk reduction brought by nicorandil was 60%. Event rate of the present study will be lower, because drug-eluting stents are widely used to prevent restenosis in the present era. Moreover, investigators include the patients underwent coronary bypass graft in the present study. In addition, non-cardiovascular mortality is high in the patients on hemodialysis. Considering all the various factors together, investigators estimated the study sample size.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, End Stage Renal Disease
Keywords
Nicorandil, Randomized control study, Hemodialysis, Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicorandil
Arm Type
Active Comparator
Arm Description
Nicorandil was administered orally (15mg/day).
Arm Title
Non-nicorandil
Arm Type
No Intervention
Arm Description
Nicorandil was not administered.
Intervention Type
Drug
Intervention Name(s)
Nicorandil
Other Intervention Name(s)
Sigmart
Intervention Description
15mg per day
Primary Outcome Measure Information:
Title
The primary endpoint is composite of :1) cardiovascular death 2)sudden cardiac death 3)nonfatal myocardial infarction 4)Hospitalization for recurrent symptomatic myocardial ischemia 5)stroke
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Total mortality
Time Frame
2 years
Title
revascularization therapy
Time Frame
2 years
Title
hospitalization for heart failure
Time Frame
2 years
Title
hospitalization for peripheral artery disease
Time Frame
2 years
Title
newly onset of atrial fibrillation
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisao Ogawa, MD, PhD
Organizational Affiliation
Kumamoto University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17379051
Citation
Ishii H, Toriyama T, Aoyama T, Takahashi H, Yamada S, Kasuga H, Ichimiya S, Kanashiro M, Mitsuhashi H, Maruyama S, Matsuo S, Naruse K, Matsubara T, Murohara T. Efficacy of oral nicorandil in patients with end-stage renal disease: a retrospective chart review after coronary angioplasty in Japanese patients receiving hemodialysis. Clin Ther. 2007 Jan;29(1):110-22. doi: 10.1016/j.clinthera.2007.12.020.
Results Reference
background
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Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
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