Study design and rationale of "Synergistic effect of combination therapy with cilostazol and ProbUcol on plaque stabilization and lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial.
Study design and rationale of "Synergistic effect of combination therapy with cilostazol and ProbUcol on plaque stabilization and lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial.
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研究设计和基本原理“与西洛舍唑和普罗库尔结合疗法对牙菌斑稳定和病变回归的协同作用（安全）”研究：一项双盲随机对照多中心临床试验。
DOI：
10.1186/1745-6215-12-10
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发表时间：
2011-01-12
期刊：
影响因子：
2.5
通讯作者：
SECURE Investigators
中科院分区：
文献类型：
--
作者：
Ko YG;Kim BK;Lee BK;Kang WC;Choi SH;Kim SW;Lee JH;Lee M;Honda Y;Fitzerald PJ;Shim WH;SECURE Investigators
普罗布考是一种降低胆固醇的药物，但同时也降低高密度脂蛋白胆固醇，已被证明可预防动脉粥样硬化的进展。抗血小板药物西洛他唑具有多种抗动脉粥样硬化特性，在先前的临床试验中也显示可减少再狭窄。最近的实验研究表明，普罗布考和西洛他唑在预防动脉粥样硬化方面可能具有协同作用，可能是通过抑制炎症反应和促进胆固醇流出。西洛他唑和普罗布考联合治疗对斑块稳定和病变消退的协同作用（SECURE）研究设计为双盲、随机、对照、多中心临床试验，使用血管内超声和虚拟组织学研究西洛他唑和普罗布考联合治疗与西洛他唑单药治疗相比对斑块体积和组成的影响。主要终点是基线和9个月随访之间指数中间病变斑块体积的变化。次要终点包括斑块组成的变化、经皮冠状动脉介入治疗靶病变支架植入后的新生内膜生长、脂质成分和动脉粥样硬化和炎症相关生物标志物的血清水平。共有118例患者将入组本研究。SECURE研究将提供关于联合治疗对脂质组成和动脉粥样硬化相关生物标志物的影响的重要信息，从而深入了解西洛他唑和普罗布考预防动脉粥样硬化进展的机制。临床试验（NCT）：NCT 01031667
Probucol, a cholesterol-lowering agent that paradoxically also lowers high-density lipoprotein cholesterol has been shown to prevent progression of atherosclerosis. The antiplatelet agent cilostazol, which has diverse antiatherogenic properties, has also been shown to reduce restenosis in previous clinical trials. Recent experimental studies have suggested potential synergy between probucol and cilostazol in preventing atherosclerosis, possibly by suppressing inflammatory reactions and promoting cholesterol efflux. The Synergistic Effect of combination therapy with Cilostazol and probUcol on plaque stabilization and lesion REgression (SECURE) study is designed as a double-blind, randomised, controlled, multicenter clinical trial to investigate the effect of cilostazol and probucol combination therapy on plaque volume and composition in comparison with cilostazol monotherapy using intravascular ultrasound and Virtual Histology. The primary end point is the change in the plaque volume of index intermediate lesions between baseline and 9-month follow-up. Secondary endpoints include change in plaque composition, neointimal growth after implantation of stents at percutaneous coronary intervention target lesions, and serum levels of lipid components and biomarkers related to atherosclerosis and inflammation. A total of 118 patients will be included in the study. The SECURE study will deliver important information on the effects of combination therapy on lipid composition and biomarkers related to atherosclerosis, thereby providing insight into the mechanisms underlying the prevention of atherosclerosis progression by cilostazol and probucol. ClinicalTrials (NCT): NCT01031667
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影响因子：
11.3
作者：
Nasu, Kenya;Tsuchikane, Etsuo;Suzuki, Takahiko
通讯作者：
Suzuki, Takahiko
影响因子：
15.9
作者：
SASAHARA, M;RAINES, EW;ROSS, R
通讯作者：
ROSS, R
影响因子：
5.3
作者：
Okutsu, Reiko;Yoshikawa, Tomohiro;Yabuuchi, Youichi
通讯作者：
Yabuuchi, Youichi
DOI：
10.1161/01.atv.9.4.462
发表时间：
1989-07-01
期刊：
ARTERIOSCLEROSIS
影响因子：
--
作者：
FRANCESCHINI, G;SIRTORI, M;SIRTORI, CR
通讯作者：
SIRTORI, CR
DOI：
10.1016/s0735-1097(01)01783-1
发表时间：
2002-02-20
影响因子：
24
作者：
Sawayama, Y;Shimizu, C;Hayashi, J
通讯作者：
Hayashi, J