Unique ID issued by UMIN | UMIN000003307 |
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Receipt number | 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 | 2020/05/26 11:00:28 |
Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease, PROSPECTIVE
Probucol Trial for Secondary Prevention of Atherosclerotic Events (PROSPECTIVE)
Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease, PROSPECTIVE
Probucol Trial for Secondary Prevention of Atherosclerotic Events (PROSPECTIVE)
Japan | Asia(except Japan) |
Dyslipidemia with high LDL cholesterol (LDL-C) levels, Coronary artery disease
Cardiology |
Others
NO
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
Safety,Efficacy
Confirmatory
Explanatory
Phase III
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)
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Continuing the former lipid lowering therapy
Adding probucol with the former lipid lowering therapy
20 | years-old | <= |
Not applicable |
Male and Female
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
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
860
1st name | Shizuya |
Middle name | |
Last name | Yamashita |
Osaka University Hospital
Department of Cardiovascular Medicine
565-0871
Yamadaoka 2-15, Suita, Osaka, Japan
06-6879-3633
shizu@cardiology.med.osaka-u.ac.jp
1st name | Daisaku |
Middle name | |
Last name | Masuda |
Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine
565-0871
Yamadaoka 2-2, Suita, Osaka, Japan
06-6879-3633
http://www.ibri-kobe.org/
masuda@cardiology.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
Foundation for Biomedical Research and Innovation
Non profit foundation
Japan
Osaka University Hospitaal
2-2 Yamaadaoka Suita Osaka
06-6879-5111
rinri@hp-crc.osaka-u.ac.jp
NO
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
2010 | Year | 03 | Month | 09 | Day |
http://www.ibri-kobe.org/
Unpublished
https://www.jstage.jst.go.jp/article/jat/advpub/0/advpub_55327/_article
876
Patients were randomly assigned to two treatment groups and followed up for more than 3 years. The primary end point was a composite of cerebrovascular and cardiovascular events, its incidence of the primary end point showed a trend to be lower in the probucol group compared with that in the control group despite reduced HDL-C without serious adverse events.
2020 | Year | 05 | Month | 26 | Day |
2020 | Year | 04 | Month | 24 | Day |
PROSPECTIVE is a multicenter, randomized, prospective study that recruited 876 Japanese patients with CHD and dyslipidemia with an low-density lipoprotein (LDL)-cholesterol (HDL-C) level of > 140 mg/dL without medication or those treated with lipid-lowering drugs.
Lipid-lowering agents were administered during the study period in the control group (n=438), and probucol 500 mg/day was added to lipid-lowering therapy in the probucol group (n=438). Patients were randomly assigned to two treatment groups by adjusting the LDL-C level and presence of diabetes and hypertension and followed up for more than 3 years.
There was no significant difference in the frequencies of SAEs between the two groups.
The primary end point was a composite of cerebrovascular and cardiovascular events (cardiovascular disease death including sudden death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization). The secondary end point was carotid intima-media thickness in a subset of patients. The incidence of the primary end point showed a trend to be lower in the probucol group compared with that in the control group despite reduced HDL-C without serious adverse events. Anti-atherogenic effects of probucol may be attributed to its potent antioxidative function and enhancement of reverse cholesterol transport. Since there was no statistical significance between the probucol and control groups despite a marked reduction of HDL-C, further studies on the clinical outcomes of probucol on top of conventional therapy may be necessary in the future
Completed
2009 | Year | 09 | Month | 30 | Day |
2009 | Year | 11 | Month | 06 | Day |
2010 | Year | 03 | Month | 01 | Day |
2016 | Year | 02 | Month | 28 | Day |
2016 | Year | 02 | Month | 28 | Day |
2018 | Year | 03 | Month | 28 | Day |
2018 | Year | 12 | Month | 31 | Day |
2010 | Year | 03 | Month | 09 | Day |
2020 | Year | 05 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003994
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