NCT00848562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

4.9 years

First QC Date

February 19, 2009

Last Update Submit

February 19, 2009

Conditions

Acute Myocardial InfarctionCongestive Heart Failure

Keywords

sudden cardiac death

Outcome Measures

Primary Outcomes (1)

  • Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure)

    Jan 1, 2002 to Dec 31, 2006

Secondary Outcomes (1)

  • All-cause mortality

    Jan 1, 2002 to Dec 31, 2006

Study Arms (1)

Nicorandil

EXPERIMENTAL
Drug: Nicorandil

Interventions

NicorandilDRUG

Oral administration of nicorandil (15 mg/day)

Nicorandil

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toujinkai Hospital

Kyoto, Kyoto, 612-8026, Japan

Location

MeSH Terms

Conditions

Heart FailureDeath, Sudden, Cardiac

Interventions

Nicorandil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart ArrestDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitratesOrganic ChemicalsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

January 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 20, 2009

Record last verified: 2009-02

Locations

JP(1)