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

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction; Congestive Heart Failure
• Interventions: Drug: Nicorandil

• Registration Number: NCT00848562
• Lead Sponsor: Toujinkai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-02
• Study First Submitted: 2009-02-19
• Study First Submitted QC: 2009-02-19
• Last Update Submitted: 2009-02-19
• Study First Posted: 2009-02-20
• Last Update Posted: 2009-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nicorandil	Nicorandil	-

Primary Outcome Measures

Name	Time	Method
Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure)	Jan 1, 2002 to Dec 31, 2006

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	Jan 1, 2002 to Dec 31, 2006

Trial Locations

Locations (1)

Toujinkai Hospital; 🇯🇵 Kyoto, Japan