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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003307
Receipt No. R000003994
Scientific Title Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease, PROSPECTIVE
Date of disclosure of the study information 2010/03/09
Last modified on 2019/03/15

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Basic information
Public title Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease, PROSPECTIVE
Acronym Probucol Trial for Secondary Prevention of Atherosclerotic Events (PROSPECTIVE)
Scientific Title Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease, PROSPECTIVE
Scientific Title:Acronym Probucol Trial for Secondary Prevention of Atherosclerotic Events (PROSPECTIVE)
Region
Japan Asia(except Japan)

Condition
Condition Dyslipidemia with high LDL cholesterol (LDL-C) levels, Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the additional effect of probucol with other lipid-lowering drugs for the prevention of cerebrovascular and cardiovascular events in patients with prior coronary events and high LDL cholesterol level
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes Cerebrovascular or cardiovascular events and the duration from the enrollment.
Following diseases were recognized;
1) death due to cardiovascular diseases including sudden death
2) nonfatal myocardial infarction
3) nonfatal cerebral stroke (excluding transient ischemic attack, TIA)
4) hospitalization for unstable angina
5) hospitalization for heart failure
6) coronary revascularization (percutaneous coronary interventions, PCI or coronary artery bypass graft, CABG)
Key secondary outcomes 1) All deaths
2) All cardiovascular and cerebrovascular diseases
3) Event free survival time
4) Levels of the mean intima media thickness(IMT) of carotid arteries and their changes
5) Levels of max IMT in common or internal carotid arteries and their changes
6) Severe adverse events and their frequency

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Continuing the former lipid lowering therapy
Interventions/Control_2 Adding probucol with the former lipid lowering therapy
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 1) Patients who have been diagnosed as dyslipidemia with high LDL-C level
2) Patients who are taking lipid lowering drugs
3) Patients whose LDL-C level was from 100 to 200 mg/dl by the blood test within 8 weeks before the informed consents (LDL-C should be calculated by the Friedewald formula: LDL-C= TC-HDL-C-TG/5)
4) Patients who have a history of following coronary heart diseases;
myocardial infarction or angina pectoris, and whose onset of the disease was more than 3 months before
CABG which was performed more than 3 months before
PCI which was undergone more than nine months before or no restenosis which was diagnosed by the follow-up coronary angiography, 6-9 months after PCI
5) Patients who are suffering from mild to moderate heart failure. (NYHA classification I or II)
6) Patients who are over 20 years old at the time of informed consent
7) Patients whose hepatic and renal functions are normal, AST<100 IU/L, ALT<100 IU/L, serum creatinine<1.5 IU/L, data from the blood test within 4 weeks before the time of informed consents
8) Patients who have given written informed consent for participating in this study
Key exclusion criteria 1) Patients who have taken probucol within 6 months before the time of informed consents
2) Patients who are currently taking cyclosporin
3) Patients who have a past history of hypersensitivity reactions to probucol
4) Patients who have already been diagnosed as familial hypercholesterolemia based on NICE Clinical Guideline 71 (Atherosclerosis 2003;168:1-14)
5) Patients whose TG level was over 400 mg/dl within 8 weeks before the time of informed consents
6) Patients whose HbA1c level was over 8 % by the latest blood test
7) Patients who have electrocardiographically been confirmed to have frequent multifocal ventricular arrhythmia
8) Patients who have been confirmed to have atrial fibrillation (Af) including paroxysmal Af
9) Patients whose QTc interval in resting electrocardiogram was >450 msec in males or >470 msec in females, respectively
10) Patients who have congestive heart failure or unstable angina
11) Patients who have been participating in other clinical trials
12) Patients who are pregnant, lactating or have the possibility of pregnancy or the wish of pregnancy within this study period
13) Patients whom were considered inappropriate by the doctors for participation in the current study
Target sample size 860

Research contact person
Name of lead principal investigator
1st name Shizuya
Middle name
Last name Yamashita
Organization Osaka University Hospital
Division name Department of Cardiovascular Medicine
Zip code 565-0871
Address Yamadaoka 2-15, Suita, Osaka, Japan
TEL 06-6879-3633
Email shizu@cardiology.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Daisaku
Middle name
Last name Masuda
Organization Osaka University Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code 565-0871
Address Yamadaoka 2-2, Suita, Osaka, Japan
TEL 06-6879-3633
Homepage URL http://www.ibri-kobe.org/
Email masuda@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Foundation for Biomedical Research and Innovation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Hospitaal
Address 2-2 Yamaadaoka Suita Osaka
Tel 06-6879-5111
Email rinri@hp-crc.osaka-u.ac.jp

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 大阪大学医学部附属病院(大阪府)、京都大学医学部附属病院(京都府)、千葉大学医学部付属病院(千葉県)、順天堂大学医学部附属順天堂医院(東京都)、東邦大学医療センター大橋病院(千葉県)、東邦大学医療センター佐倉病院(千葉県)、国立循環器病センター(大阪府)、中国労災病院(広島県)、山口大学医学部附属病院(山口県)、桜橋渡辺病院(大阪府)、医療法人社団 湖東記念病院(滋賀県)、大阪赤十字病院(大阪府)、りんくう総合医療センター市立泉佐野病院(大阪府)、社会福祉法人恩賜財団済生会支部大阪府済生会千里病院(大阪府)、独立行政法人国立病院機構 京都医療センター(京都府)、健保連大阪中央病院(大阪府)、医療法人 川崎病院(兵庫県)、済生会習志野病院(千葉県)、近畿大学医学部附属病院(大阪府)、
大阪警察病院(大阪府)、国保松戸市立病院(千葉県)、日本大学医学部附属病院(東京都)、神戸大学医学部附属病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、独立行政法人 労働者健康福祉機構 関西労災病院(兵庫県)、大津赤十字病院(滋賀県)、兵庫医科大学附属病院(兵庫県)
その他、順次追加の予定である

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 09 Day

Related information
URL releasing protocol http://www.ibri-kobe.org/
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
2009 Year 09 Month 30 Day
Date of IRB
2009 Year 11 Month 06 Day
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
2016 Year 02 Month 28 Day
Date of closure to data entry
2016 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 28 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 09 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003994

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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