Back to resultsEffect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease (IMPACTonIMT)
Primary Purpose
Hyperlipidemias
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HMG-CoA Reductase Inhibitor
Probucol
Cilostazol
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemias focused on measuring Hyperlipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Probucol, Cilostazol
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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%
- 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
Sites / Locations
- Dong-A Medical Center
- Samsung Medical Center
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Boramae Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Group C
Arm Description
HMGCoA reductase inhibitor continued
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
The change of Biomarkers(1)
Metabolic index: Lipid profile (TC, LDL-C, HDL-C, TG)
The change of Biomarkers(2)
Inflammatory index: High sensitive C-reactive protein (hsCRP)
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).
Full Information
NCT ID
NCT01291641
First Posted
January 31, 2011
Last Updated
September 18, 2019
Sponsor
Seoul National University Hospital
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01291641
Brief Title
Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease
Acronym
IMPACTonIMT
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Hyperlipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Probucol, Cilostazol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
HMGCoA reductase inhibitor continued
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID
Intervention Type
Drug
Intervention Name(s)
HMG-CoA Reductase Inhibitor
Intervention Description
During the study period, HMGCoA reductase inhibitor is continuously administered to the patients.
Dosage regimen: following the package insert of each HMGCoA reductase inhibitor
Intervention Type
Drug
Intervention Name(s)
Probucol
Other Intervention Name(s)
HMG-CoA Reductase Inhibitor
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Probucol, HMG-CoA Reductase Inhibitor
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation
Description
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.
Time Frame
Baseline(screening), 3years
Secondary Outcome Measure Information:
Title
Time from enrollment date to the onset of composite cerebrovascular events
Description
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.
Time Frame
enrollment date, onset date(during study period, 3years)
Title
Number of composite cerebrovascular and cardiovascular events(including intervention)
Description
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).
Time Frame
enrollment date, onset date(during study period, 3years)
Title
The change of Biomarkers(1)
Description
Metabolic index: Lipid profile (TC, LDL-C, HDL-C, TG)
Time Frame
enrollment date ,onset date(during study period, 3years)
Title
The change of Biomarkers(2)
Description
Inflammatory index: High sensitive C-reactive protein (hsCRP)
Time Frame
enrollment date ,onset date(during study period, 3years)
Title
The change of Biomarkers(3)
Description
Oxidation index:oxidized LDL
The change of biomarkers, t-test will be done by treatment arm(Group A vs B, Group A vs C).
Time Frame
enrollment date ,onset date(during study period, 3years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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%
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Hee Oh, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cheol Ho Kim, M.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Kim, M.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Moo-Hyun Kim, M.D.
Organizational Affiliation
Dong-A medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A Medical Center
City
Seogu
State/Province
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
12. IPD Sharing Statement
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Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease
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