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: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
End Stage Renal Disease
Drug: Nicorandil (15mg/day)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Kumamoto University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 268
Study Start Date: June 2008
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicorandil Drug: Nicorandil (15mg/day)
15mg per day
Other Name: Sigmart
No Intervention: Non-nicorandil

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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475123

Locations
Japan
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, Japan, 860-8556
Sponsors and Collaborators
Kumamoto University
Investigators
Study Chair: Hisao Ogawa, MD, PhD Kumamoto University
  More Information

Publications:
Responsible Party: Yasuhiro Nagayoshi, principal investigator, Kumamoto University
ClinicalTrials.gov Identifier: NCT01475123     History of Changes
Other Study ID Numbers: CVM-2008-PRECON
Study First Received: November 16, 2011
Last Updated: April 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kumamoto University:
Nicorandil
Randomized control study
Hemodialysis
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Kidney Diseases
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Nicorandil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014