Background:

2

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:

2

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:

2

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:

2

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)