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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Korea Otsuka Pharmaceutical Co., Ltd.
• Treatments: Cilostazol; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Probucol

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