UMIN-CTR Clinical Trial

Basic information
Public title	Toyama Anti-arteriosclerosis and Plaque Assessment Trial by Aggressive Lipid Lowering Therapy with Pitavastatin in Peripheral Artery Disease
Acronym	TULIP
Scientific Title	Toyama Anti-arteriosclerosis and Plaque Assessment Trial by Aggressive Lipid Lowering Therapy with Pitavastatin in Peripheral Artery Disease
Scientific Title:Acronym	TULIP
Region	Japan

Condition
Condition	Patients with peripheral artery disease and hypercholesterolemia
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of intensive with conventional lipid lowering therapy, on patients with peripheral artery disease and hypercholesterolemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	claudication time on Treadmill exercise test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	intensive lipid lowering therapy with Pitavastatin, 1 to 4mg once daily, to achieve serum LDL cholesterol level less than 80mg/dl.
Interventions/Control_2	conventional lipid lowering therapy with Pitavastatin, 1 to 4mg once daily, to achieve serum LDL cholesterol level less than 120mg/dl in patients without coronary heart disease or less than 100mg/dl in patients with coronary heart disease.
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	40 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patient without coronary artery disease, whose LDL cholesterol >= 120mg/dl 2) Patient with coronary artery disease, whose LDL cholesterol >= 100mg/dl 3) Ankle Brachial Pressure Index (ABI) <= 0.9
Key exclusion criteria	1) Following "contraindication" or "essentially contraindication" of pitavastatin as follows: severe liver injury or biliary obstruction patients taking cyclosporin pregnant or possible pregnant women or breast-feeding women patients with renal dysfunction and taking fibrates 2) patients already taking pitavastatin 3) patients with maintenance dialysis 4) patients who plan to undergo or underwent bilateral lower limb revascularization within within 3 months. 5) patients with severe peripheral artery disease (Fontaine classification class 4) 6) patient with previous cerebral hemorrhage 7) patients who judged inadequate by the co-execution doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Inoue
Organization	University of Toyama
Division name	Graduate school of medicine and pharmaceutical science, The Second Department of Internal Medicine
Zip code
Address	2630 Sugitani, Toyama
TEL	076-434-7297
Email

Public contact
Name of contact person	1st name Middle name Last name Tomoki Kameyama
Organization	University of Toyama
Division name	Graduate school of medicine and pharmaceutical science, The Second Department of Internal Medicine
Zip code
Address	2630 Sugitani, Toyama
TEL	076-434-7297
Homepage URL
Email

Sponsor
Institute	The Second Department of Internal Medicine, University of Toyama, Graduate school of medicine and pharmaceutical science,
Institute
Department

Funding Source
Organization	The Second Department of Internal Medicine, University of Toyama, Graduate school of medicine and pharmaceutical science,
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	2010 Year 06 Month 01 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	Preinitiation
Date of protocol fixation	2010 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 05 Month 17 Day
Last modified on	2010 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004399

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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