Overview

This trial is active, not recruiting.

Conditions coronary artery disease, end stage renal disease
Treatment nicorandil
Phase phase 4
Sponsor Kumamoto University
Start date June 2008
End date June 2011
Trial size 268 participants
Trial identifier NCT01475123, CVM-2008-PRECON

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Nicorandil was administered orally (15mg/day).
nicorandil Sigmart
15mg per day
(No Intervention)
Nicorandil was not administered.

Primary Outcomes

Measure
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 Outcomes

Measure
Total mortality
time frame: 2 years
revascularization therapy
time frame: 2 years
hospitalization for heart failure
time frame: 2 years
hospitalization for peripheral artery disease
time frame: 2 years
newly onset of atrial fibrillation
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Kumamoto University.