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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 5
- 主要终点
- Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are at least 20 y of age at the time of informed consent (male or female)
- •Subjects with coronary heart disease longer than 3 months.
- •Subjects being treated with HMGCoA reductase inhibitors(Statins)
- •Subjects with an max IMT equal to or greater than 1.2 mm
- •Subjects with an LDL-Cholesterol less than 200mg/dl
- •Subjects whose voluntary written informed consent is obtained for participation in this study
排除标准
- •Subjects who took probucol within 6 months before participation of the study
- •Subjects who took cilostazol within 3 months before participation of the study
- •Subjects with a history of hypersensitivity to probucol or cilostazol
- •Subjects with homozygous familial hyperlipidemia*
- •Subjects with a triglyceride ( TG) level greater than 400mg/dL at screening
- •Subjects with uncontrolled diabetes : HbA1c level greater than 9%
- •Subjects with New York Heart Association (NYHA) classification: Class Ⅲ and Ⅳ
- •Subjects with a QTc interval greater than 450msec(male) 470msec(female)
- •Subjects with serious ventricular arrythmias (frequent episodes of multifocal ventricular extrasystole)
- •Subjects with atrial fibrillation (including paroxysmal AF)
- •Subjects with unstable angina
- •Subjects with liver and kidney functions that satisfy the following criteria - AST or ALT >100 IU/L, serum creatinine >1.5 mg/dL
- •Subjects who are participating in another clinical trial
- •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
- •Subjects with clinically significant disorders of blood coagulation
- •Subjects who are not considered by the physicians to be appropriate to participate in this trial for any other reason
研究组 & 干预措施
Group A
HMGCoA reductase inhibitor continued
干预措施: HMG-CoA Reductase Inhibitor (Drug)
Group B
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID
干预措施: Probucol (Drug)
Group C
HMGCoA reductase inhibitor continued + Probucol 250 mg PO, BID + Cilostazol 100 mg PO, BID
干预措施: Cilostazol (Drug)
结局指标
主要结局
Difference of Carotid artery IMT (mean IMT) between screening and treatment completion(3 years after) or discontinuation
时间窗: 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.
次要结局
- The change of Biomarkers(2)(enrollment date ,onset date(during study period, 3years))
- Time from enrollment date to the onset of composite cerebrovascular events(enrollment date, onset date(during study period, 3years))
- Number of composite cerebrovascular and cardiovascular events(including intervention)(enrollment date, onset date(during study period, 3years))
- The change of Biomarkers(1)(enrollment date ,onset date(during study period, 3years))
- The change of Biomarkers(3)(enrollment date ,onset date(during study period, 3years))
研究者
Byung-Hee Oh
Professor of Internal Medicine/Cardiology
Seoul National University Hospital