Efficacy and safety of traditional Chinese medicine compound DLTM formula on CAC progression in patients with stable CHD: Study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Pharmacological Research - Modern Chinese Medicine Pub Date : 2025-04-18 DOI:10.1016/j.prmcm.2025.100614

Qian Xu , Wenting Wang , Xiaochen Wang , Wenwu Liu , Chuyao Qi , Mengmeng Zhu , Jing Cui , Yiwen Li , Yanfei Liu , Yue Liu

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引用次数: 0

Abstract

Introduction

Coronary artery calcification (CAC) is closely associated with adverse cardiovascular events in patients with stable coronary heart disease (CHD). Effective treatments specifically targeting CAC progression are still lacking, representing an urgent clinical need. Traditional Chinese medicine (TCM) has been widely used in the prevention and treatment of CHD, playing a crucial synergistic role. This study aims to evaluate the efficacy and safety of DLTM formula in preventing CAC progression in patients with stable CHD.

Methods

This multicenter, randomized, double-blind, placebo-controlled trial will be conducted at Xiyuan Hospital of China Academy of Chinese Medical Sciences, the Second Hospital of Anhui Medical University, and Suzhou Hospital of Traditional Chinese Medicine. A total of 194 eligible participants are expected to be recruited. Participants will be randomly assigned to the DLTM formula group and the placebo control group in a 1:1 ratio. All participants will receive a 12-week pharmacological intervention and will be followed up for 9 months after completing the medication. The primary outcome measure is the coronary artery calcium volume score, and the secondary outcome measures include the Agatston score, coronary plaque burden, and the frequency and intensity of angina attacks. Adverse events will be closely monitored throughout the trial. The trial is registered at the International Traditional Medicine Clinical Trial Registry (ITMCTR2024000060).

Results

The trial will assess changes in coronary imaging parameters, clinical symptom assessments, and safety profiles, providing objective evidence for the DLTM formula's efficacy and safety.

Discussion

This study is expected to fill the clinical treatment gap for CAC, clarify the therapeutic value of the DLTM formula, and offer a novel strategy for managing stable CHD.

Abstract Image

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中药复方DLTM方对稳定型冠心病患者CAC进展的疗效和安全性：多中心、随机、双盲、安慰剂对照试验研究方案

在稳定性冠心病（CHD）患者中，冠状动脉钙化（CAC）与不良心血管事件密切相关。针对CAC进展的有效治疗仍然缺乏，这代表了迫切的临床需求。中医药在冠心病的防治中得到广泛应用，发挥着至关重要的协同作用。本研究旨在评价DLTM方预防稳定型冠心病患者CAC进展的有效性和安全性。方法多中心、随机、双盲、安慰剂对照试验在中国中医科学院西苑医院、安徽医科大学第二医院和苏州中医医院进行。预计总共将招募194名符合条件的参与者。参与者将按1:1的比例随机分配到DLTM配方组和安慰剂对照组。所有参与者将接受为期12周的药物干预，并在完成药物治疗后随访9个月。主要指标是冠状动脉钙容量评分，次要指标包括Agatston评分、冠状动脉斑块负担、心绞痛发作的频率和强度。在整个试验过程中将密切监测不良事件。该试验已在国际传统医学临床试验注册中心（ITMCTR2024000060）注册。该试验将评估冠状动脉成像参数的变化、临床症状评估和安全性，为DLTM配方的有效性和安全性提供客观证据。本研究有望填补CAC的临床治疗空白，阐明DLTM方的治疗价值，并为稳定型冠心病的治疗提供新的策略。

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来源期刊

Pharmacological Research - Modern Chinese Medicine

CiteScore

1.60

自引率

0.00%

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