Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Toujinkai Hospital
ClinicalTrials.gov Identifier:
NCT00848562
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Congestive Heart Failure
 Drug: Nicorandil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Toujinkai Hospital:

Primary Outcome Measures:
  • Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure) [ Time Frame: Jan 1, 2002 to Dec 31, 2006 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Jan 1, 2002 to Dec 31, 2006 ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: January 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicorandil Drug: Nicorandil
Oral administration of nicorandil (15 mg/day)

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848562

Locations
Japan
Toujinkai Hospital
Kyoto, Japan, 612-8026
Sponsors and Collaborators
Toujinkai Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00848562     History of Changes
Other Study ID Numbers: NICO-HDPCI-1
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Toujinkai Hospital:
sudden cardiac death

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Death
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Nicorandil
 Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013