Overview

This trial is active, not recruiting.

Condition hyperlipidemias
Treatments hmgcoa reductase inhibitor, hmgcoa reductase inhibitor + probucol, hmgca reductase inhibitor + probucol + cilostazol
Phase phase 4
Sponsor Seoul National University Hospital
Collaborator Korea Otsuka Pharmaceutical Co.,Ltd.
Start date March 2011
End date December 2016
Trial size 342 participants
Trial identifier NCT01291641, IMT-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
HMGCoA reductase inhibitor continued
hmgcoa reductase inhibitor
During the study period, HMGCoA reductase inhibitor is continuously administered to the patients. Dosage regimen: following the package insert of each HMGCoA reductase inhibitor
(Experimental)
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
hmgcoa reductase inhibitor + probucol
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)
(Experimental)
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID
hmgca reductase inhibitor + probucol + cilostazol
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 Outcomes

Measure
Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation
time frame: Baseline(screening), 3years

Secondary Outcomes

Measure
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)

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

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
Principal investigator Cheol Ho Kim, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Seoul National University Hospital.