National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
PLoS One. 2024 Jul 16;19(7):e0307074. doi: 10.1371/journal.pone.0307074. eCollection 2024.
Despite the available secondary preventive treatments, the management of stable coronary artery disease (SCAD) remains challenging. Intermediate coronary lesion (ICL), defined as luminal stenosis between 50% and 70%, is a key stage of SCAD. However, existing therapeutic strategies are limitated in delaying plaque progression and associated with various adverse effects and economic burdens. Qing-Xin-Jie-Yu Granules (QXJYG) with proven anti-platelet, anti-inflammatory, and lipid-lowering effects may compensate for the drawbacks of current treatments and can be tested as a complementary therapy. Therefore, this study aims to investigate the efficacy and safety of QXJYG in treating ICL, with a particular focus on its impact on myocardial ischemia and plaque progression.
This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 120 participants with ICL will be randomly assigned to two groups in a 1:1 ratio. In addition to basic medications, the intervention group will receive QXJYG, while the control group will receive a placebo for over 6 months, followed by a 12-month follow-up. The primary efficacy outcome is computed tomography-derived fractional flow reserve. The secondary outcomes include the degree of coronary stenosis, coronary artery calcification score, Gensini score, Seattle Angina Questionnaire score, high-sensitivity C-reactive protein, matrix metalloproteinase-9, blood lipids, and carotid artery ultrasound parameters. Major adverse cardiovascular events are recorded as endpoints. The safety outcomes include composite events of bleeding, laboratory test results, and adverse events. Clinical visits are scheduled at baseline, every 2 months during the treatment, and after a 12-month follow-up.
This trial is anticipated to yield reliable results to verify the efficacy and safety of QXJYG in the treatment of ICL, which will provide novel insights to help address the prevailing therapeutic dilemma of ICL, thereby facilitating for the management of SCAD.
Chinese Clinical Trial Registry, ChiCTR2200059262. Registered on April 27, 2022.
尽管有可用的二级预防治疗方法，稳定型冠状动脉疾病 (SCAD) 的管理仍然具有挑战性。中间冠状动脉病变 (ICL) 定义为管腔狭窄 50% 至 70%，是 SCAD 的关键阶段。然而，现有的治疗策略在延缓斑块进展方面存在局限性，并且与各种不良反应和经济负担有关。具有抗血小板、抗炎和降血脂作用的清心解毒颗粒 (QXJYG) 可能弥补当前治疗方法的不足，可以作为一种补充治疗进行测试。因此，本研究旨在探讨 QXJYG 治疗 ICL 的疗效和安全性，特别是其对心肌缺血和斑块进展的影响。
这是一项多中心、随机、双盲、安慰剂对照试验。共纳入 120 例 ICL 患者，按 1:1 比例随机分为两组。除基础药物治疗外，干预组给予 QXJYG，对照组给予安慰剂，治疗 6 个月后进行 12 个月随访。主要疗效终点为计算机断层扫描衍生的血流储备分数。次要结局包括冠状动脉狭窄程度、冠状动脉钙化积分、Gensini 评分、西雅图心绞痛问卷评分、高敏 C 反应蛋白、基质金属蛋白酶-9、血脂和颈动脉超声参数。主要不良心血管事件作为终点记录。安全性结局包括出血、实验室检查结果和不良事件的复合事件。临床访视安排在基线、治疗期间每 2 个月和 12 个月随访时进行。
本试验预计将产生可靠的结果，以验证 QXJYG 治疗 ICL 的疗效和安全性，为解决 ICL 目前的治疗困境提供新的思路，从而有助于 SCAD 的管理。
中国临床试验注册中心，ChiCTR2200059262。注册于 2022 年 4 月 27 日。
