Coronary Artery DiseasePhase 4NCT01475123
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
A Phase 4 study testing Nicorandil in people with Coronary Artery Disease and End Stage Renal Disease, run by Kumamoto University at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, End Stage Renal Disease
- What is being tested?
- Nicorandil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2008to Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Kumamoto, 860-8556
About this study
Official title: 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.
Read the 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 400 cases in total (200 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.
- Conditions
- Coronary Artery Disease, End Stage Renal Disease
- Being tested
- Nicorandil
- Keywords
- Nicorandil, Randomized control study, Hemodialysis, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicorandilDrug
Also called Sigmart
15mg per day
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil | Active comparator | Nicorandil was administered orally (15mg/day). Receives: Drug: Nicorandil |
| Non-nicorandil | No intervention | Nicorandil was not administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (5)
Total mortality
Measured: 2 years
revascularization therapy
Measured: 2 years
hospitalization for heart failure
Measured: 2 years
hospitalization for peripheral artery disease
Measured: 2 years
newly onset of atrial fibrillation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2011 (estimated)
- Study startJun 2008
- Primary completionJun 2011
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kumamoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasuhiro Nagayoshi, Kumamoto University
- Investigators
- Hisao Ogawa, MD, PhD, Study chair, Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475123
- Sponsor's protocol ID
- CVM-2008-PRECON
- Status last verified
- Sep 2026
- First submitted
- 16 Nov 2011
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 17379051