UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000089
Receipt number R000000131
Scientific Title Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP
Date of disclosure of the study information 2005/08/31
Last modified on 2009/12/22 22:00:25

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Basic information

Public title

Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

Acronym

J-WIND-KATP

Scientific Title

Japan-Working Groups of Acute Myocardial Infarction for the Reduction of Necrotic Damage by a K-ATP

Scientific Title:Acronym

J-WIND-KATP

Region

Japan


Condition

Condition

Patients with AMI who are candidates for PCI(first episode of AMI)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

to evaluate whether nicorandil as an adjunctive therapy for AMI reduces myocardial infarct size and improves regional wall motion.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1) estimated infarct size and
(2) left ventricular function (left ventricular ejection fraction and end-diastolic volume) and regional wall motion.

Key secondary outcomes

(1) survival rate
(2)cardiovascular events (ie, cardiac death, nonfatal re-infarction, re-hospitalization because of cardiac disease, revascularization)
(3) reperfusion injury (ie, malignant ventricular arrhythmia during reperfusion periods, re-elevation of ST-segment, worsening of chest pain)
(4) the association of SNPs of ANP-related genes with response to ANP treatment


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In the nicorandil group, after a bolus injection of nicorandil(0.067 mg/kg), it is continuously infused intravenously at 1.67ug/kg·min for 24h.

Interventions/Control_2

In the control group, seline is continuously infused intravenously for 24h.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

79 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Age 20–79 years
2. Chest pain of more than 30 min
3. 0.1 mV ST-segment elevation in 2 contiguous ECG leads
4. Admission to hospital within 12 h of symptom onset
5. First episode of AMI
6. Candidates for PCI

Key exclusion criteria

1. History of old myocardial infarction
2. Left main coronary artery stenosis
3. Severe liver and/or kidney dysfunction
4. Suspected aortic dissection
5. History of coronary artery bypass graft
6. History of allergic response to drugs
7. Severe hypovolemia
8. Right ventricular infarction

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Kitakaze

Organization

National Cardiovascular Center

Division name

Cardiovascular Division

Zip code


Address

5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan

TEL

06-6833-5012

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Clinical Study Support Center Japan (CSSCJ)

Division name

J-WIND office

Zip code


Address


TEL

06-6836-0077

Homepage URL


Email



Sponsor or person

Institute

National Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Japan Cardiovascular Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Lancet. 2008 Dec 22;370(9605):2102.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2001 Year 09 Month 19 Day

Date of IRB


Anticipated trial start date

2001 Year 10 Month 01 Day

Last follow-up date

2007 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2005 Year 08 Month 29 Day

Last modified on

2009 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000131


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name