Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil

Coronary Artery Disease Clinical Trial

Official title:

Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01475123
• Other study ID #: CVM-2008-PRECON
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 2008
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Kumamoto University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 268
• Est. completion date: December 2024
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Myocardial Ischemia

Intervention

Drug:
• Nicorandil
15mg per day

Locations

Country	Name	City	State
Japan	Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Kumamoto University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 years
Secondary	Total mortality		2 years
Secondary	revascularization therapy		2 years
Secondary	hospitalization for heart failure		2 years
Secondary	hospitalization for peripheral artery disease		2 years
Secondary	newly onset of atrial fibrillation		2 years