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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001872
Receipt No. 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

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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
Email 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
Email asato@md.tsukuba.ac.jp

Sponsor
Institute Cardiovascular Division, University of Tsukuba, Graduate School of Comprehensive Human Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002242

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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