Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients

Acute Myocardial Infarction Clinical Trial

Official title:

Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848562
• Other study ID #: NICO-HDPCI-1
• Status: Completed
• Phase: N/A
• First received: February 19, 2009
• Last updated: February 19, 2009
• Start date: January 2002
• Est. completion date: December 2006

Study information

• Verified date: February 2009
• Source: Toujinkai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

Survival after invasive coronary revascularization is worse in patients with chronic kidney disease than in those without it. The investigators aimed to examine whether oral administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive potassium channel opener, could improve the survival of end-stage renal disease patients with coronary artery disease by inhibiting cardiac death after coronary revascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Hemodialysis patients with coronary artery disease who had undergone a successful first PCI with bare-metal stents between July 1, 2001 and December 31, 2003.

Exclusion Criteria:

• Subjects with moderate or worse cardiac valvular disease or old myocardial infarction at the point of first PCI.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Congestive Heart Failure
• Heart Failure
• Myocardial Infarction

Intervention

Drug:
• Nicorandil
Oral administration of nicorandil (15 mg/day)

Locations

Country	Name	City	State
Japan	Toujinkai Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Toujinkai Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure)		Jan 1, 2002 to Dec 31, 2006	No
Secondary	All-cause mortality		Jan 1, 2002 to Dec 31, 2006	Yes