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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000089 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Patients with AMI who are candidates for PCI(first episode of AMI) | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 600 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
Public contact | |||||||
Name of contact person |
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Organization | Clinical Study Support Center Japan (CSSCJ) | ||||||
Division name | J-WIND office | ||||||
Zip code | |||||||
Address | |||||||
TEL | 06-6836-0077 | ||||||
Homepage URL | |||||||
Sponsor | |
Institute | National Cardiovascular Center |
Institute | |
Department |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 |