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Completed

NCT Number: NCT00848562

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toujinkai Hospital

Kyoto, 612-8026, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nicorandil

Drug

Oral administration of nicorandil (15 mg/day)

Primary outcomes

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

    Time frame: Jan 1, 2002 to Dec 31, 2006

Secondary outcomes

  1. All-cause mortality

    Time frame: Jan 1, 2002 to Dec 31, 2006

Sponsors and collaborators

Lead sponsor

Toujinkai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Feb 20, 2009
Registry last updated
Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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