UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001520 |
|---|---|
| Receipt number | R000001834 |
| Scientific Title | Plaque-Stabilizing Action of Pitavastatin in Coronary Artery Disease |
| Date of disclosure of the study information | 2008/11/25 |
| Last modified on | 2013/07/31 06:33:48 |
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Basic information
Public title
Plaque-Stabilizing Action of Pitavastatin in Coronary Artery Disease
Acronym
Plaque-Stabilizing Action of Pitavastatin in Coronary Artery Disease (PLATINA)
Scientific Title
Plaque-Stabilizing Action of Pitavastatin in Coronary Artery Disease
Scientific Title:Acronym
Plaque-Stabilizing Action of Pitavastatin in Coronary Artery Disease (PLATINA)
Region
| Japan |
Condition
Condition
Patients who have undergone successful percutaneous coronary intervention
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the ability of pitavastatin to influence the coronary plaque composition in Japanese patients undergoing successful percutaneous coronary intervention, using Virtual-Histology intravascular ultrasound, optical coherence tomography and multidetector-row CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in characteristics and volume of coronary plaques using Virtual- Histology intravascular ultrasound(VH-IVUS), optical coherence tomography(OCT) and multidetector-row CT(MDCT).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin 4mg/day
Interventions/Control_2
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 who have undergone elective percutaneous coronary intervention and need cholesterol-lowering therapy. And also patients satisfying all of the inclusion criteria below.
(1)Patients with culprit lesions in one or two coronary arteries for whom percutaneous coronary intervention is indicated.
(2)Patients with lesions satisfying the registration criteria shown below. Two or fewer lesions can be registered in each vessel.
1.Non-restenotic lesion with less than 75% stenosis by visual estimation in main vessel.
2.Vessels which are visually estimated to be 3.0 mm or more in diameter at the evaluation site.
3.Vessels which curve at less than 60 degrees and in which IVUS and OCT can be inserted.
4.Vessels showing moderate or less calcification into which IVUS and OCT can be inserted.
(3)Patients in whom successful PCI is accomplished in all the culprit lesions without the complications listed below.
1.Chest pain and/or ST segment elevation persisting for more than 10 minutes during the operation.
2.Slow flow or no reflow
3.Side branch occlusion
4.Coronary artery perforation
5.Distal embolism which prevented TIMI flow grade 3
6.Coronary dissection more severe than type C
7.Cardiopulmonary resuscitation
8.Ventricular tachyarrhythmia necessitating continuous drug treatment
9.Acute cardiac insufficiency
10.Intratracheal intubation
11.Use of IABP
(4)Patients with hypercholesterolemia as defined by the criteria below.
1.TC>220mg/dL
2.LDL-C>140mg/dL
3.Patients in whom cholesterol-lowering treatment is judged to be necessary by the investigator
(5)Patients 20 years or older at the time of provision of consent
(6)Patients giving written consent on their own volition after being provided sufficient explanation about the method and purpose of the trial.
Key exclusion criteria
(1)Patients already receiving HMG-CoA reductase inhibitors (statin).
(2)Patients who have received statins less than one year before.
(3)Patients in whom the culprit lesion is in the left main trunk
(4)Patients having triple-vessel disease and need PCI for all the three main branches.
(5)Patients who had previous PCI on the lesion under evaluation.
(6)Patients who have plaque in a non-culprit site on the PCI vessel and might require PCI for it during the treatment period.
(7)Patients with cardiogenic shock
(8)Patients with refractory ventricular tachyarrhythmia or fibrillation necessitating intravenous drug treatment or a defibrillator.
(9)Patients with acute impulse-conducting disorder necessitating temporary insertion of a pacemaker.
(10)Patients receiving cyclosporine.
(11)Patients with allergy to pitavastatin or any other component of LIVALO.
(12)Patients who are judged to be ineligible by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Igarashi |
Organization
Hokkaido Social Insurance Hospital
Division name
Cardiovascular center
Zip code
Address
1-8-3-18 Nakanoshima, Toyohira-ku, Sapporo Hokkaido 062-8618
TEL
011-831-5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teppei Sugaya |
Organization
Hokkaido Social Insurance Hospital
Division name
Cardiovascular center
Zip code
Address
1-8-3-18 Nakanoshima, Toyohira-ku, Sapporo Hokkaido 062-8618
TEL
011-831-5151
Homepage URL
Sponsor or person
Institute
Hokkaido social insurance hospital
Institute
Department
Personal name
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
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 | 25 | 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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | 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 | 21 | Day |
Last modified on
| 2013 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001834
