HyperlipidemiasPhase 4IMPACTonIMTNCT01291641
Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease
A Phase 4 study testing HMG-CoA Reductase Inhibitor, Probucol and Cilostazol in people with Hyperlipidemias, run by Seoul National University Hospital at 5 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the additional effect of probucol or concomitant administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean IMT) at year 1, 2, and 3. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hyperlipidemias
- What is being tested?
- HMG-CoA Reductase Inhibitor, Probucol and Cilostazol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Mar 2011to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Subjects who are at least 20 y of age at the time of informed consent (male or female)
- 2) Subjects with coronary heart disease longer than 3 months.
- 3) Subjects being treated with HMGCoA reductase inhibitors(Statins)
- 4) Subjects with an max IMT equal to or greater than 1.2 mm
- 5) Subjects with an LDL-Cholesterol less than 200mg/dl
- 6) Subjects whose voluntary written informed consent is obtained for participation in this study
Who cannot join
- 1) Subjects who took probucol within 6 months before participation of the study
- 2) Subjects who took cilostazol within 3 months before participation of the study
- 3) Subjects with a history of hypersensitivity to probucol or cilostazol
- 4) Subjects with homozygous familial hyperlipidemia*
- 5) Subjects with a triglyceride ( TG) level greater than 400mg/dL at screening
- 6) Subjects with uncontrolled diabetes : HbA1c level greater than 9%
Show all 16Show fewer
- 7) Subjects with New York Heart Association (NYHA) classification: Class Ⅲ and Ⅳ
- 8) Subjects with a QTc interval greater than 450msec(male) 470msec(female)
- 9) Subjects with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole)
- 10) Subjects with atrial fibrillation (including paroxysmal AF)
- 11) Subjects with unstable angina
- 12) Subjects with liver and kidney functions that satisfy the following criteria - AST or ALT >100 IU/L, serum creatinine >1.5 mg/dL
- 13) Subjects who are participating in another clinical trial
- 14) Subjects with pregnant or possibly pregnant without appropriate contraception control. Appropriate contraception control means that Oral contraception for greater than 4 weeks, surgical contraception including loop insertion, condom use etc. Women who has no possibility of pregnancy because of surgery or menopause should not be regarded the subject with possibly pregnant
- 15) Subjects with clinically significant disorders of blood coagulation
- 16) Subjects who are not considered by the physicians to be appropriate to participate in this trial for any other reason
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Dong-A Medical Center
Seogu, Busan, 602-715
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Samsung Medical Center
Seoul, Gangnam-Gu, 135-710
Seoul National University Hospital
Seoul, 110-744
Boramae Medical Center
Seoul, 156-707
About this study
Official title: Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients With Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy: A Randomized, Multicenter, Multinational Study
The purpose of this study is to evaluate the additional effect of probucol or concomitant administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean IMT) at year 1, 2, and 3.
Read the detailed description
Hyperlipidemic patients who are currently receiving HMGCoA reductase inhibitors(Statins) will be randomized Group A(Control), Group B(Probucol only added group) or Group C(Probucol and cilostazol added group) . Randomization will be done by the minimization method, controlling for the following factors: Country(Korea vs China) and max IMT (≥2.0mm vs.<2.0mm).
Group A : HMGCoA reductase inhibitor continued
Group B : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
Group C : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID +Cilostazol 100 mg PO, BID
- Conditions
- Hyperlipidemias
- Being tested
- HMG-CoA Reductase Inhibitor, Probucol, Cilostazol
- Keywords
- Hyperlipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Probucol, Cilostazol
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMG-CoA Reductase InhibitorDrug
During the study period, HMGCoA reductase inhibitor is continuously administered to the patients.
Dosage regimen: following the package insert of each HMGCoA reductase inhibitor
ProbucolDrug
Also called HMG-CoA Reductase Inhibitor
In addition to the continued HMGCoA reductase inhibitor treatment, probucol is administered.
Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner)
CilostazolDrug
Also called Probucol, HMG-CoA Reductase Inhibitor
In addition to the continued HMGCoA reductase inhibitor treatment, probucol and cilostazol are administered.
Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner) Cilostazol 100-mg tablet, twice daily by the oral route
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | HMGCoA reductase inhibitor continued Receives: Drug: HMG-CoA Reductase Inhibitor |
| Group B | Active comparator | HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID Receives: Drug: Probucol |
| Group C | Active comparator | HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation
For primary endpoint of Carotid artery IMT, t-test will be conducted for the mean IMT and variation by treatment arm(Group A vs B, Group A vs C). The 2-sided significance level is 5%. Morever, Mantel - Haenszel method can be accepted considering stratification factor or Sub-analysis can be done by each stratum in case of categorical variables.
Measured: Baseline(screening), 3years
Secondary outcomes (5)
Time from enrollment date to the onset of composite cerebrovascular events
- Cardiovascular death
- Myocardial infarction
- Cerebral infarction
- Unstable angina and cardiac failure, required hospitalization
- Coronary revascularization, required hospitalization
- PCI and coronary artery bypass grafting [CABG]
Kaplan-Meier method will be conducted for the time from enrollment date to the onset of composite cerebrovascular and cardiovascular events by treatment arm(Group A vs B, Group A vs C). Overall survival curves and progression-free survival curves are estimated per treatment arm.
Measured: enrollment date, onset date(during study period, 3years)
Number of composite cerebrovascular and cardiovascular events(including intervention)
- Cardiovascular death
- Myocardial infarction
- Cerebral infarction
- Unstable angina and cardiac failure, required hospitalization
- Coronary revascularization, required hospitalization
- PCI and coronary artery bypass grafting [CABG]
For the number of composite cerebrovascular and cardiovascular events (including intervention) t-test will be done by treatment arm(Group A vs B, Group A vs C).
Measured: enrollment date, onset date(during study period, 3years)
The change of Biomarkers(1)
Metabolic index: Lipid profile (TC, LDL-C, HDL-C, TG)
Measured: enrollment date ,onset date(during study period, 3years)
The change of Biomarkers(2)
Inflammatory index: High sensitive C-reactive protein (hsCRP)
Measured: enrollment date ,onset date(during study period, 3years)
The change of Biomarkers(3)
Oxidation index:oxidized LDL
The change of biomarkers, t-test will be done by treatment arm(Group A vs B, Group A vs C).
Measured: enrollment date ,onset date(during study period, 3years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Byung-Hee Oh, Seoul National University Hospital
- Investigators
- Byung-Hee Oh, M.D., Study chair, Seoul National University HospitalCheol Ho Kim, M.D., Principal investigator, Seoul National University Bundang HospitalSang-Hyun Kim, M.D., Principal investigator, SMG-SNU Boramae Medical CenterMoo-Hyun Kim, M.D., Principal investigator, Dong-A medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291641
- Sponsor's protocol ID
- IMT-01
- Acronym
- IMPACTonIMT
- Status last verified
- Sep 2019
- First submitted
- 31 Jan 2011
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manzato E. Scandinavian simvastatin study (4S). Lancet. 1994 Dec 24-31;344(8939-8940):1767; author reply 1767-8. No abstract available.
PubMed 7997016Plehn JF, Davis BR, Sacks FM, Rouleau JL, Pfeffer MA, Bernstein V, Cuddy TE, Moye LA, Piller LB, Rutherford J, Simpson LM, Braunwald E. Reduction of stroke incidence after myocardial infarction with pravastatin: the Cholesterol and Recurrent Events (CARE) study. The Care Investigators. Circulation. 1999 Jan 19;99(2):216-23. doi: 10.1161/01.cir.99.2.216.
PubMed 9892586Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998 Nov 5;339(19):1349-57. doi: 10.1056/NEJM199811053391902.
PubMed 9841303Barnhart JW, Sefranka JA, McIntosh DD. Hypocholesterolemic effect of 4,4'-(isopropylidenedithio)-bis(2,6-di-t-butylphenol) (probucol). Am J Clin Nutr. 1970 Sep;23(9):1229-33. doi: 10.1093/ajcn/23.9.1229. No abstract available.
PubMed 5450842Tomikawa M, Nakayasu T, Tawara K, Abiko Y. Effect of probucol on serum lipoprotein levels in normal and dyslipoproteinemic mice. Atherosclerosis. 1981 Oct;40(2):101-13. doi: 10.1016/0021-9150(81)90029-0.
PubMed 6946776Tawara K, Tomikawa M, Abiko Y. Mode of action of probucol in reducing serum cholesterol in mice. Jpn J Pharmacol. 1986 Jan;40(1):123-33. doi: 10.1254/jjp.40.123.
PubMed 3959347Kita T, Nagano Y, Yokode M, Ishii K, Kume N, Ooshima A, Yoshida H, Kawai C. Probucol prevents the progression of atherosclerosis in Watanabe heritable hyperlipidemic rabbit, an animal model for familial hypercholesterolemia. Proc Natl Acad Sci U S A. 1987 Aug;84(16):5928-31. doi: 10.1073/pnas.84.16.5928.
PubMed 3475709Ishigami M, Yamashita S, Sakai N, Hirano K, Arai T, Maruyama T, Takami S, Koyama M, Kameda-Takemura K, Matsuzawa Y. High-density lipoproteins from probucol-treated patients have increased capacity to promote cholesterol efflux from mouse peritoneal macrophages loaded with acetylated low-density lipoproteins. Eur J Clin Invest. 1997 Apr;27(4):285-92. doi: 10.1046/j.1365-2362.1997.1040657.x.
PubMed 9134376Rinninger F, Wang N, Ramakrishnan R, Jiang XC, Tall AR. Probucol enhances selective uptake of HDL-associated cholesteryl esters in vitro by a scavenger receptor B-I-dependent mechanism. Arterioscler Thromb Vasc Biol. 1999 May;19(5):1325-32. doi: 10.1161/01.atv.19.5.1325.
PubMed 10323786Matsuzawa Y, Yamashita S, Funahashi T, Yamamoto A, Tarui S. Selective reduction of cholesterol in HDL2 fraction by probucol in familial hypercholesterolemia and hyperHDL2 cholesterolemia with abnormal cholesteryl ester transfer. Am J Cardiol. 1988 Jul 25;62(3):66B-72B. doi: 10.1016/s0002-9149(88)80055-9.
PubMed 3394656Daida H, Kuwabara Y, Yokoi H, Nishikawa H, Takatsu F, Nakata Y, Kutsumi Y, Oshima S, Nishiyama S, Ishiwata S, Kato K, Nishimura S, Miyauchi K, Kanoh T, Yamaguchi H. Effect of probucol on repeat revascularization rate after percutaneous transluminal coronary angioplasty (from the Probucol Angioplasty Restenosis Trial [PART]). Am J Cardiol. 2000 Sep 1;86(5):550-2, A9. doi: 10.1016/s0002-9149(00)01013-4.
PubMed 11009277Tardif JC, Cote G, Lesperance J, Bourassa M, Lambert J, Doucet S, Bilodeau L, Nattel S, de Guise P. Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group. N Engl J Med. 1997 Aug 7;337(6):365-72. doi: 10.1056/NEJM199708073370601.
PubMed 9241125Anderson TJ, Meredith IT, Yeung AC, Frei B, Selwyn AP, Ganz P. The effect of cholesterol-lowering and antioxidant therapy on endothelium-dependent coronary vasomotion. N Engl J Med. 1995 Feb 23;332(8):488-93. doi: 10.1056/NEJM199502233320802.
PubMed 7830729Sawayama Y, Shimizu C, Maeda N, Tatsukawa M, Kinukawa N, Koyanagi S, Kashiwagi S, Hayashi J. Effects of probucol and pravastatin on common carotid atherosclerosis in patients with asymptomatic hypercholesterolemia. Fukuoka Atherosclerosis Trial (FAST). J Am Coll Cardiol. 2002 Feb 20;39(4):610-6. doi: 10.1016/s0735-1097(01)01783-1.
PubMed 11849859Yamashita S, Bujo H, Arai H, Harada-Shiba M, Matsui S, Fukushima M, Saito Y, Kita T, Matsuzawa Y. Long-term probucol treatment prevents secondary cardiovascular events: a cohort study of patients with heterozygous familial hypercholesterolemia in Japan. J Atheroscler Thromb. 2008 Dec;15(6):292-303. doi: 10.5551/jat.e610. Epub 2008 Dec 6.
PubMed 19060422
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients With Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy: A Randomized, Multicenter, Multinational Study
- ClinicalTrials.gov ID
- NCT01291641
- Acronym / sponsor ID
- IMPACTonIMT / IMT-01
- Conditions
- Hyperlipidemias
- Keywords
- Hyperlipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Probucol, Cilostazol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Otsuka Pharmaceutical Co., Ltd.
- Study start
- Mar 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the additional effect of probucol or concomitant administration of cilostazol and probucol on mean carotid artery intima-media thickness (mean IMT) at year 1, 2, and 3.
Detailed description
Hyperlipidemic patients who are currently receiving HMGCoA reductase inhibitors(Statins) will be randomized Group A(Control), Group B(Probucol only added group) or Group C(Probucol and cilostazol added group) . Randomization will be done by the minimization method, controlling for the following factors: Country(Korea vs China) and max IMT (≥2.0mm vs.<2.0mm).
Group A : HMGCoA reductase inhibitor continued
Group B : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
Group C : HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID +Cilostazol 100 mg PO, BID
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: HMG-CoA Reductase InhibitorHMGCoA reductase inhibitor continued |
| Group B | Active comparator | Drug: ProbucolHMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID |
| Group C | Active comparator | Drug: CilostazolHMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1) Subjects who are at least 20 y of age at the time of informed consent (male or female)
- 2) Subjects with coronary heart disease longer than 3 months.
- 3) Subjects being treated with HMGCoA reductase inhibitors(Statins)
- 4) Subjects with an max IMT equal to or greater than 1.2 mm
- 5) Subjects with an LDL-Cholesterol less than 200mg/dl
Key exclusion criteria (16 listed)
- 1) Subjects who took probucol within 6 months before participation of the study
- 2) Subjects who took cilostazol within 3 months before participation of the study
- 3) Subjects with a history of hypersensitivity to probucol or cilostazol
- 4) Subjects with homozygous familial hyperlipidemia*
- 5) Subjects with a triglyceride ( TG) level greater than 400mg/dL at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMG-CoA Reductase InhibitorDuring the study period, HMGCoA reductase inhibitor is continuously administered to the patients. Dosage regimen: following the package insert of each HMGCoA reductase inhibitor | Drug | Group A |
| ProbucolAlso: HMG-CoA Reductase InhibitorIn addition to the continued HMGCoA reductase inhibitor treatment, probucol is administered. Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner) | Drug | Group B |
| CilostazolAlso: Probucol, HMG-CoA Reductase InhibitorIn addition to the continued HMGCoA reductase inhibitor treatment, probucol and cilostazol are administered. Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner) Cilostazol 100-mg tablet, twice daily by the oral route | Drug | Group C |
Primary outcome
Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation
Time frame: Baseline(screening), 3years
For primary endpoint of Carotid artery IMT, t-test will be conducted for the mean IMT and variation by treatment arm(Group A vs B, Group A vs C). The 2-sided significance level is 5%. Morever, Mantel - Haenszel method can be accepted considering stratification factor or Sub-analysis can be done by each stratum in case of categorical variables.
5 secondary outcomes
Time from enrollment date to the onset of composite cerebrovascular events
Time frame: enrollment date, onset date(during study period, 3years)
Number of composite cerebrovascular and cardiovascular events(including intervention)
Time frame: enrollment date, onset date(during study period, 3years)
The change of Biomarkers(1)
Time frame: enrollment date ,onset date(during study period, 3years)
The change of Biomarkers(2)
Time frame: enrollment date ,onset date(during study period, 3years)
The change of Biomarkers(3)
Time frame: enrollment date ,onset date(during study period, 3years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Results publication: PubMed 7997016Manzato E. Scandinavian simvastatin study (4S). Lancet. 1994 Dec 24-31;344(8939-8940):1767; author reply 1767-8. No abstract available.
- Results publication: PubMed 9892586Plehn JF, Davis BR, Sacks FM, Rouleau JL, Pfeffer MA, Bernstein V, Cuddy TE, Moye LA, Piller LB, Rutherford J, Simpson LM, Braunwald E. Reduction of stroke incidence after myocardial infarction with pravastatin: the Cholesterol and Recurrent Events (CARE) study. The Care Investigators. Circulation. 1999 Jan 19;99(2):216-23. doi: 10.1161/01.cir.99.2.216.
- Results publication: PubMed 9841303Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998 Nov 5;339(19):1349-57. doi: 10.1056/NEJM199811053391902.
- Results publication: PubMed 5450842Barnhart JW, Sefranka JA, McIntosh DD. Hypocholesterolemic effect of 4,4'-(isopropylidenedithio)-bis(2,6-di-t-butylphenol) (probucol). Am J Clin Nutr. 1970 Sep;23(9):1229-33. doi: 10.1093/ajcn/23.9.1229. No abstract available.
- Results publication: PubMed 6946776Tomikawa M, Nakayasu T, Tawara K, Abiko Y. Effect of probucol on serum lipoprotein levels in normal and dyslipoproteinemic mice. Atherosclerosis. 1981 Oct;40(2):101-13. doi: 10.1016/0021-9150(81)90029-0.
- Results publication: PubMed 3959347Tawara K, Tomikawa M, Abiko Y. Mode of action of probucol in reducing serum cholesterol in mice. Jpn J Pharmacol. 1986 Jan;40(1):123-33. doi: 10.1254/jjp.40.123.
- Results publication: PubMed 3475709Kita T, Nagano Y, Yokode M, Ishii K, Kume N, Ooshima A, Yoshida H, Kawai C. Probucol prevents the progression of atherosclerosis in Watanabe heritable hyperlipidemic rabbit, an animal model for familial hypercholesterolemia. Proc Natl Acad Sci U S A. 1987 Aug;84(16):5928-31. doi: 10.1073/pnas.84.16.5928.
- Results publication: PubMed 9134376Ishigami M, Yamashita S, Sakai N, Hirano K, Arai T, Maruyama T, Takami S, Koyama M, Kameda-Takemura K, Matsuzawa Y. High-density lipoproteins from probucol-treated patients have increased capacity to promote cholesterol efflux from mouse peritoneal macrophages loaded with acetylated low-density lipoproteins. Eur J Clin Invest. 1997 Apr;27(4):285-92. doi: 10.1046/j.1365-2362.1997.1040657.x.
- Results publication: PubMed 10323786Rinninger F, Wang N, Ramakrishnan R, Jiang XC, Tall AR. Probucol enhances selective uptake of HDL-associated cholesteryl esters in vitro by a scavenger receptor B-I-dependent mechanism. Arterioscler Thromb Vasc Biol. 1999 May;19(5):1325-32. doi: 10.1161/01.atv.19.5.1325.
- Results publication: PubMed 3394656Matsuzawa Y, Yamashita S, Funahashi T, Yamamoto A, Tarui S. Selective reduction of cholesterol in HDL2 fraction by probucol in familial hypercholesterolemia and hyperHDL2 cholesterolemia with abnormal cholesteryl ester transfer. Am J Cardiol. 1988 Jul 25;62(3):66B-72B. doi: 10.1016/s0002-9149(88)80055-9.
- Results publication: PubMed 11009277Daida H, Kuwabara Y, Yokoi H, Nishikawa H, Takatsu F, Nakata Y, Kutsumi Y, Oshima S, Nishiyama S, Ishiwata S, Kato K, Nishimura S, Miyauchi K, Kanoh T, Yamaguchi H. Effect of probucol on repeat revascularization rate after percutaneous transluminal coronary angioplasty (from the Probucol Angioplasty Restenosis Trial [PART]). Am J Cardiol. 2000 Sep 1;86(5):550-2, A9. doi: 10.1016/s0002-9149(00)01013-4.
- Results publication: PubMed 9241125Tardif JC, Cote G, Lesperance J, Bourassa M, Lambert J, Doucet S, Bilodeau L, Nattel S, de Guise P. Probucol and multivitamins in the prevention of restenosis after coronary angioplasty. Multivitamins and Probucol Study Group. N Engl J Med. 1997 Aug 7;337(6):365-72. doi: 10.1056/NEJM199708073370601.
Related trials for Hyperlipidemias
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byung-Hee Oh, M.D. study chair
Seoul National University Hospital
Cheol Ho Kim, M.D. principal investigator
Seoul National University Bundang Hospital
Sang-Hyun Kim, M.D. principal investigator
SMG-SNU Boramae Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HMG-CoA Reductase Inhibitor, Probucol and Cilostazol in people with Hyperlipidemias, run by Seoul National University Hospital at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation (time frame: Baseline(screening), 3years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291641, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.