Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
Coronary Artery Disease
End Stage Renal Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis|
- 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 ] [ Designated as safety issue: No ]
- Total mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- revascularization therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- hospitalization for heart failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- hospitalization for peripheral artery disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- newly onset of atrial fibrillation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Nicorandil
Nicorandil was administered orally (15mg/day).
15mg per day
Other Name: Sigmart
No Intervention: Non-nicorandil
Nicorandil was not administered.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475123
|Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University|
|Kumamoto, Japan, 860-8556|
|Study Chair:||Hisao Ogawa, MD, PhD||Kumamoto University|