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Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial

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Abstract

Background

Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction.

Objective

This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale.

Methods

This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment.

Discussion

This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411)

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Access to Data

The access to the final trial dataset is rigidly restricted to investigators who are authorized by the steering committee and any activity is recorded. There are contractual agreements that limit such access for investigators.

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Authors and Affiliations

  1. Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China

    Yu-jie Wu, Bo Deng, Si-bo Wang, Yang Yang &  Lian-sheng Wang

  2. Department of Cardiology, Anqing Municipal Hospital Affiliated to Anhui Medical University, Anqing, Jiangsu Province, 246003, China

    Rui Qiao

  3. Department of Cardiology, Huai’an First People’s Hospital, Huai’an, Jiangsu Province, 223300, China

    Xi-wen Zhang

  4. Department of Cardiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, 221006, China

    Yuan Lu

  5. Department of Cardiology, Pukou Branch of Jiangsu People’s Hospital, Nanjing, 211899, China

    Li Wang

  6. Department of Cardiology, Hai’an People’s Hospital, Nantong, Jiangsu Province, 226699, China

    Shun-zhong Gu

  7. Department of Cardiology, the Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, 211199, China

    Yu-qing Zhang

  8. Department of Cardiology, Qixia District Hospital of Nanjing City, Nanjing, 210046, China

    Kai-qiao Li

  9. Department of Cardiology, the First People’s Hospital of Kunshan Affiliated to Jiangsu University, Kunshan, Jiangsu Province, 215300, China

    Zong-liang Yu

  10. Department of Cardiology, Nanjing Lishui District Hospital of Traditional Chinese Medicine, Nanjing, 211299, China

    Li-xing Wu

  11. Department of Cardiology, Nanjing Meishan Hospital, Nanjing, 210039, China

    Sheng-biao Zhao & Shuang-lin Zhou

Authors
  1. Yu-jie Wu
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  2. Bo Deng
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  3. Si-bo Wang
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  4. Rui Qiao
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  5. Xi-wen Zhang
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  6. Yuan Lu
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  7. Li Wang
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  8. Shun-zhong Gu
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  9. Yu-qing Zhang
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  10. Kai-qiao Li
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  11. Zong-liang Yu
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  12. Li-xing Wu
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  13. Sheng-biao Zhao
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  14. Shuang-lin Zhou
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  15. Yang Yang
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  16. Lian-sheng Wang
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Contributions

Wang LS and Yang Y designed this study. Wu YJ was a major contributor to writing the manuscript. Deng B and Wang SB made necessary revisions to the manuscript. Qiao R, Zhang XW, Lu Y, Wang L, Gu SZ, Zhang YQ, Li KQ, Yu ZL, Wu LX, Zhao SB, and Zhou SL were major contributors to patients’ enrollment and management from other study centers. All authors read and approved the final version.

Corresponding author

Correspondence to Lian-sheng Wang.

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Conflict of Interest

The authors declare no competing interests. The authors wish to acknowledge Tasly Pharmaceutical Group Co., Ltd. for providing financial support and relevant information about CDDP. As this is an investigator-initiated trial, the authors designed and conducted the study. Data collection has been managed by independent data recorders at each participating center where the data originated. The funding body does not interfere in the analysis and interpretation of the data.

Confidentiality

Confidentiality in the collection of personal information is protected in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects in China.

Additional information

Supported by Tasly Pharmaceutical Group Co., Ltd. (No. 303100031BA20)

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Wu, Yj., Deng, B., Wang, Sb. et al. Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial. Chin. J. Integr. Med. 29, 1059–1065 (2023). https://doi.org/10.1007/s11655-023-3648-6

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  • DOI: https://doi.org/10.1007/s11655-023-3648-6

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