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Completed

NCT Number: NCT01291641

Effect of Probucol and/or Cilostazol on Mean IMT in Patients With Coronary Heart dIsease

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.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dong-A Medical Center, Seogu, Busan, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HMG-CoA Reductase Inhibitor

Drug

During the study period, HMGCoA reductase inhibitor is continuously administered to the patients.

Dosage regimen: following the package insert of each HMGCoA reductase inhibitor

Probucol

Drug

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)

Other names: HMG-CoA Reductase Inhibitor

Cilostazol

Drug

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

Other names: Probucol, HMG-CoA Reductase Inhibitor

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time from enrollment date to the onset of composite cerebrovascular events

    Time frame: enrollment date, onset date(during study period, 3years)

    • 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.

  2. Number of composite cerebrovascular and cardiovascular events(including intervention)

    Time frame: enrollment date, onset date(during study period, 3years)

    • 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).

  3. The change of Biomarkers(1)

    Time frame: enrollment date ,onset date(during study period, 3years)

    Metabolic index: Lipid profile (TC, LDL-C, HDL-C, TG)

  4. The change of Biomarkers(2)

    Time frame: enrollment date ,onset date(during study period, 3years)

    Inflammatory index: High sensitive C-reactive protein (hsCRP)

  5. The change of Biomarkers(3)

    Time frame: enrollment date ,onset date(during study period, 3years)

    Oxidation index:oxidized LDL

    The change of biomarkers, t-test will be done by treatment arm(Group A vs B, Group A vs C).

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study 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

Acronym: IMPACTonIMT

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Feb 8, 2011
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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