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.

Yu-jie WU; Bo Deng; Si-bo Wang; Rui Qiao; Xi-wen Zhang; Yuan LU; Li Wang; Shun-zhong GU; Yu-qing Zhang; Kai-qiao LI; Zong-liang YU; Li-xing WU; Sheng-biao Zhao; Shuang-lin Zhou; Yang Yang; Lian-sheng Wang

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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.

Author: Yu-Jie WU ¹ ; Bo DENG ¹ ; Si-Bo WANG ¹ ; Rui QIAO ² ; Xi-Wen ZHANG ³ ; Yuan LU ⁴ ; Li WANG ⁵ ; Shun-Zhong GU ⁶ ; Yu-Qing ZHANG ⁷ ; Kai-Qiao LI ⁸ ; Zong-Liang YU ⁹ ; Li-Xing WU ¹⁰ ; Sheng-Biao ZHAO ¹¹ ; Shuang-Lin ZHOU ¹¹ ; Yang YANG ¹ ; Lian-Sheng WANG ¹²
Author Information

1. Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
2. Department of Cardiology, Anqing Municipal Hospital Affiliated to Anhui Medical University, Anqing, Jiangsu Province, 246003, China.
3. Department of Cardiology, Huai'an First People's Hospital, Huai'an, Jiangsu Province, 223300, China.
4. Department of Cardiology, the Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province, 221006, China.
5. Department of Cardiology, Pukou Branch of Jiangsu People's Hospital, Nanjing, 211899, China.
6. Department of Cardiology, Hai'an People's Hospital, Nantong, Jiangsu Province, 226699, China.
7. Department of Cardiology, the Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, 211199, China.
8. Department of Cardiology, Qixia District Hospital of Nanjing City, Nanjing, 210046, China.
9. Department of Cardiology, the First People's Hospital of Kunshan Affiliated to Jiangsu University, Kunshan, Jiangsu Province, 215300, China.
10. Department of Cardiology, Nanjing Lishui District Hospital of Traditional Chinese Medicine, Nanjing, 211299, China.
11. Department of Cardiology, Nanjing Meishan Hospital, Nanjing, 210039, China.
12. Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China. drlswang@njmu.edu.cn.
Publication Type:Journal Article
Keywords: Compound Danshen Dripping Pills; acute anterior myocardial infarction; cardiac function; randomized controlled trial; trial design; ventricular remodeling
MeSH: Humans; ST Elevation Myocardial Infarction/therapy*; Stroke Volume; Ventricular Remodeling; Prospective Studies; Microcirculation; Ventricular Function, Left; Myocardial Infarction/etiology*; Treatment Outcome; Percutaneous Coronary Intervention/adverse effects*; Heart Failure/drug therapy*; Drugs, Chinese Herbal/therapeutic use*; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
From: Chinese journal of integrative medicine 2023;29(12):1059-1065
CountryChina
Language:English
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).