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

Sponsored by:	Toujinkai Hospital
Information provided by:	Toujinkai Hospital
ClinicalTrials.gov Identifier:	NCT00848562

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:	Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Dialysis Heart Attack Heart Failure Kidney Failure

Drug Information available for: Nicorandil

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
Nicorandil: Experimental	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

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

Keywords provided by Toujinkai Hospital:

sudden cardiac death

Study placed in the following topic categories:

Vasodilator Agents
Heart Failure
Death
Vitamin B Complex
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Trace Elements
Ischemia
Cardiovascular Agents

Antihypertensive Agents
Necrosis
Vitamins
Nicorandil
Micronutrients
Death, Sudden, Cardiac
Anti-Arrhythmia Agents
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Vasodilator Agents
Heart Failure
Death
Vitamin B Complex
Heart Diseases
Growth Substances
Myocardial Ischemia
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Ischemia
Antihypertensive Agents

Pharmacologic Actions
Necrosis
Pathologic Processes
Vitamins
Therapeutic Uses
Nicorandil
Cardiovascular Diseases
Micronutrients
Anti-Arrhythmia Agents
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on August 30, 2009