Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01475123
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2011-11-16
Brief Title:
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
Sponsor:
Kumamoto University
Organization:
Kumamoto University
Study Overview
Official Title:
Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 005 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
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 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None