UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001495 |
|---|---|
| Receipt number | R000001664 |
| Scientific Title | Investigation of MDCT Plaque Assessment in patients receiving Cholesterol lowering with Pitavastatin (IMPACT) |
| Date of disclosure of the study information | 2008/11/11 |
| Last modified on | 2017/05/31 17:46:26 |
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Basic information
Public title
Investigation of MDCT Plaque Assessment in patients receiving Cholesterol lowering with Pitavastatin (IMPACT)
Acronym
IMPACT
Scientific Title
Investigation of MDCT Plaque Assessment in patients receiving Cholesterol lowering with Pitavastatin (IMPACT)
Scientific Title:Acronym
IMPACT
Region
| Japan |
Condition
Condition
Patients with non-calcified coronary plaque detected with MDCT
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of chelesterol lowering by pitavastatin on plaque CT value compared with control group
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of the plaque CT value change between the groups
Key secondary outcomes
a. The relationship between plaque CT value and the cholesterol level.
b.The relationship between plaque CT value and the oxidative stress and inflamation marker.
c. The change of HbH1c between the groups
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
pitavastatin 2mg per day orally for 12 months.
Interventions/Control_2
Stopping smoking, life style change and increasing exercise are reccomended. When the decrease in cholesterol level is not satisfactory, plavastatin will be administered.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients with coronary non-calcified plaques detected by MDCT
2)Patients with hypercholesterolemia as defined by any of the following criteria: i) TC >220 mg/dl; ii) LDL-C >140 mg/dl; iii) cholesterol-lowering treatment is necessary in accordance with the investigator's judgement when LDL-C >120 mg/dl or TC >200 mg/dl.
3) Patients 20 years or older at the time of their consent.
4) Patients giving written consent by their own volition after being provided sufficient explanation for participation in this clinical trial.
Key exclusion criteria
1)The stenosis at the lesion where the plaque CT value estimation planned is more than 90%(AHA criteria).
2)Patients who have undergone previous PCI on the lesion site where the evaluation of coronary plaque CT value is planned.
3)Patients who might undergo PCI on the lesion where the plaque planned for the estimation of the CT value is located.
4)Patients receiving lipid-lowering drugs (pitavastatin, atorvastatin, rosvastatin).
5)Patients with familial hypercholesterolemia.
6)Patients with cardiogenic shock.
7)Patients receiving cyclosporine.
8)Patients with any allergy to pitavastatin
9)Patients with any allergy to contrast medium
10)Patients with hepatobiliary disorders.
11)Pregnant women, women suspected of being pregnant, or lactating women.
12)Patients with renal disorders or undergoing dialysis.
13)Patients who are ineligible in the opinion of the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoko Nao |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2248
nao@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Nao |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Cardiology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2248
Homepage URL
nao@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine,Department of Medicine and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine,Department of Medicine and Clinical 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
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
| 2008 | Year | 11 | Month | 11 | 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 | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2011 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 10 | Day |
Last modified on
| 2017 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001664
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