UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001521 |
|---|---|
| Receipt number | R000001495 |
| Scientific Title | Assessment of Lipophilic vs HydroPhilic Statin Therapy in Acute Myocardial Infarction: ALPS-AMI |
| Date of disclosure of the study information | 2008/11/25 |
| Last modified on | 2016/12/20 08:33:34 |
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Basic information
Public title
Assessment of Lipophilic vs HydroPhilic Statin Therapy in Acute Myocardial Infarction: ALPS-AMI
Acronym
Assessment of Statin Therapy in AMI
Scientific Title
Assessment of Lipophilic vs HydroPhilic Statin Therapy in Acute Myocardial Infarction: ALPS-AMI
Scientific Title:Acronym
Assessment of Statin Therapy in AMI
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of either hydrophilic or lipophilic statins for optimal management of dyslipidemia in patients with acute myocardial infarction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Death from any cause, cardiovascular death, myocardial infarction, stroke, and myocardial ischemia, which requires coronary intervention and/or coronary artery bypass grafting
Key secondary outcomes
Hospital admission for heart failure, and any other vascular events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Hydrophilic statin
Interventions/Control_2
Lipophilic statin
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted with acute myocardial infarction (AMI), accompanied with serum low-density lipoprotein cholesterol level at 70 mg/dl or above. The diagnosis of AMI should be done following the AHA guideline, which has been documented in Circulation 2007: 116, 2634-2653.
Key exclusion criteria
1. Advanced liver dysfunction
2. Renal failure
3. Previous history of the side effects associated with statins
4. Planned surgery for coronary artery bypass grafting
5. Known malignant disease
6. Absence of written informed consent
7. LDL cholesterol level < 70 mg/dl
8. Any other rational reason for exclusion
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uichi Ikeda |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-3486
alps@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Research Center of the ALPS-AMI Study |
Organization
Shinshu University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Asahi, 3-1-1, Matsumoto, Nagano
TEL
0263-37-3486
Homepage URL
alps@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Fund Donation
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 25 | 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
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
| 2008 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2008 | Year | 11 | Month | 23 | Day |
Last modified on
| 2016 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001495
| 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 |
