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Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall
Yu-Jie Wu1, Bo Deng1, Si-Bo Wang1
1Department of Cardiology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Insights
Compound Danshen Dripping Pills (CDDP) may improve heart function after myocardial infarction. This study evaluates CDDP
Area of Science:
- Cardiology
- Traditional Chinese Medicine
- Clinical Trials
Background:
- Ventricular remodeling post-acute anterior wall ST-segment elevation myocardial infarction (AAMI) contributes to heart failure and poor prognosis.
- Optimizing treatment for ventricular remodeling is crucial.
- Compound Danshen Dripping Pills (CDDP) show potential in protecting against ischemia-reperfusion injury and reducing ventricular remodeling.
Purpose of the Study:
- To evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI.
- To assess CDDP's impact on echocardiographic outcomes and clinical events in a larger patient cohort.
Main Methods:
- Multi-center, randomized, double-blind, placebo-controlled trial.
- 268 patients with AAMI post-primary percutaneous coronary intervention (pPCI) assigned to CDDP or placebo groups.
- 48-week follow-up assessing echocardiographic parameters (LVEF, LVEDVI, LVESVI) and secondary endpoints (NT-proBNP, arrhythmias, cardiovascular events).
Main Results:
- Echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI) at 48 weeks.
- Changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.
- Incidence of arrhythmias and major adverse cardiovascular events.
Conclusions:
- This study will provide robust data on CDDP's efficacy and safety for AAMI patients.
- Positive findings could support broader clinical recommendations for CDDP in AAMI management.
- The trial (NCT05000411) aims to establish CDDP as a viable treatment option.
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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