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Clinical trial

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

ID
Name
CVM-2008-PRECON
Description
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.
Trial arms
Trial start
2008-06-01
Estimated PCD
2011-06-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Nicorandil
15mg per day
Arms:
Nicorandil
Other names:
Sigmart
Size
268
Primary endpoint
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
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 268, 'type': 'ACTUAL'}}
Updated at
2024-03-07

1 organization

1 product

2 indications

Organization
Kumamoto University
Product
Nicorandil
Indication
Coronary Artery Disease
Indication
End-Stage Renal Disease