UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Lipophilic vs HydroPhilic Statin Therapy in Acute Myocardial Infarction: ALPS-AMI
Title of the study (Brief title)	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	Uichi Ikeda
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	Asahi 3-1-1, Matsumoto, Nagano
TEL	0263-37-3486
Email	alps@shinshu-u.ac.jp

Public contact
Name of contact person	Research Center of the ALPS-AMI Study
Organization	Shinshu University School of Medicine
Division name	Department of Cardiovascular Medicine
Address	Asahi, 3-1-1, Matsumoto, Nagano
TEL	0263-37-3486
Homepage URL
Email	alps@shinshu-u.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Shinshu University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 05 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001495