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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yasuhiro Nagayoshi, Kumamoto University
ClinicalTrials.gov Identifier:
NCT01475123
First received: November 16, 2011
Last updated: September 9, 2014
Last verified: September 2014

November 16, 2011
September 9, 2014
June 2008
June 2011   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01475123 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
Effects of Nicorandil on Cardiovascular Events in Patients With Coronary Artery Disease Receiving Hemodialysis

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Coronary Artery Disease
  • End Stage Renal Disease
Drug: Nicorandil (15mg/day)
15mg per day
Other Name: Sigmart
  • Active Comparator: Nicorandil
    Intervention: Drug: Nicorandil (15mg/day)
  • No Intervention: Non-nicorandil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
268
October 2014
June 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01475123
CVM-2008-PRECON
Yes
Yasuhiro Nagayoshi, Kumamoto University
Kumamoto University
Not Provided
Study Chair: Hisao Ogawa, MD, PhD Kumamoto University
Kumamoto University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP