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Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients With Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperlipidemias

Intervention: HMGCoA reductase inhibitor (Drug); HMGCoA reductase inhibitor + probucol (Drug); HMGCA reductase inhibitor + probucol + cilostazol (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Byung-Hee Oh, M.D., Study Chair, Affiliation: Seoul National University Hospital
Cheol Ho Kim, M.D., Principal Investigator, Affiliation: Seoul National University Bundang Hospital
Sang-Hyun Kim, M.D., Principal Investigator, Affiliation: SMG-SNU Boramae Medical Center
Moo-Hyun Kim, M.D., Principal Investigator, Affiliation: Dong-A medical center

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.

Clinical Details

Official title: Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients With Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy (IMPACT on IMT): A Randomized, Multicenter, Multinational Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation

Secondary outcome:

Time from enrollment date to the onset of composite cerebrovascular events

Number of composite cerebrovascular and cardiovascular events(including intervention)

The change of Biomarkers(1)

The change of Biomarkers(2)

The change of Biomarkers(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

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Dong-A Medical Center, Seogu, Busan 602-715, Korea, Republic of

Samsung Medical Center, Seoul, Gangnam-Gu 135-710, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of

Boramae Medical Center, Dongjak-Gu, Seoul 156-707, Korea, Republic of

Seoul National University Hospital, Jongno-gu, Seoul 110-744, Korea, Republic of

Additional Information

Starting date: March 2011
Last updated: May 19, 2015

Page last updated: August 23, 2015

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