UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001872 |
|---|---|
| Receipt number | R000002242 |
| Scientific Title | Effect of Landiolol as an adjunct to Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction |
| Date of disclosure of the study information | 2009/04/11 |
| Last modified on | 2013/10/15 14:35:25 |
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Basic information
Public title
Effect of Landiolol as an adjunct to Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction
Acronym
Ibaraki Landiolol for AMI study (i-LAND study)
Scientific Title
Effect of Landiolol as an adjunct to Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction
Scientific Title:Acronym
Ibaraki Landiolol for AMI study (i-LAND study)
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to assess the effects of landiolol on infarct size in patients with ST-segment elevation myocardial infarction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Estimated infarct size (AUC of creatine kinase)
Key secondary outcomes
1) Estimated infarct size (AUC of CK-MB)
2) Infarct size on 99mTc-MIBI SPECT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intraveous landiolol administation
Interventions/Control_2
Placebo
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) chest pain more than 30 min
2) 0.1mV ST-segment elevation in 2 contiguous ECG leads
3) admission to hospital within 12 hours of symptom onset
4) tachycardia of more than 80 beats/min
5) First episode of anterior STEMI
6) emergent primary percutaneous coronary intervention
Key exclusion criteria
1) history of OMI or CABG
2) LMT
3) suspected aortic dissection
4) systolic blood pressure of less than 90 mmHg or bradycardia of less than 60 beats/min
5) more than II-AV block or 2 bundle block
6) severe liver and/or kidney dysfunction
7) bronchial athma
8) history of beta-blocker or amiodarone
9) history of side effects or contraindication of beta-blocker
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
University of Tsukuba, Graduate School of Comprehensive Human Sciences
Division name
Cardiovascular Division
Zip code
Address
1-1-1 Tennodai Tsukuba Ibaraki Japan
TEL
029-853-3142
kaonuma@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Sato |
Organization
University of Tsukuba, Graduate School of Comprehensive Human Sciences
Division name
Cardiovascular Division
Zip code
Address
1-1-1 Tennodai Tsukuba Ibaraki Japan
TEL
029-853-3143
Homepage URL
asato@md.tsukuba.ac.jp
Sponsor or person
Institute
Cardiovascular Division, University of Tsukuba, Graduate School of Comprehensive Human Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2009 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 10 | Day |
Last modified on
| 2013 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002242
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
