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

NCT ID: NCT00848562

Last Updated: 2009-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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Conditions

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Acute Myocardial Infarction Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Nicorandil

Group Type EXPERIMENTAL

Nicorandil

Intervention Type DRUG

Oral administration of nicorandil (15 mg/day)

Interventions

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Nicorandil

Oral administration of nicorandil (15 mg/day)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Toujinkai Hospital

OTHER

Sponsor Role lead

Locations

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Toujinkai Hospital

Kyoto, Kyoto, Japan

Site Status

Countries

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Japan

Other Identifiers

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NICO-HDPCI-1

Identifier Type: -

Identifier Source: org_study_id

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