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This study is designed to evaluate the efficacy and safety of compound Danshen dropping pills (CDDP) in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation myocardial infarction(STEMI). 268 patients with acute anterior wall STEMI after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to CDDP group(n=134) and control group(n=134) with follow-up of 24 weeks. Both groups are treated with standard therapy of STEMI, with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets three times a day after pPCI and the control group treated with placebo at the same time. The primary endpoint is 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI).The secondary endpoint is the change in N terminal pro-B-type natriuretic peptide(NT-proBNP )level, arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).
Background: Progressive ventricular remodeling after acute anterior wall myocardial infarction(MI)is an important factor in the occurrence and death of heart failure. Angiotensin converting enzyme inhibitors and beta-blockers can ameliorate post-MI ventricular remodeling, but high-dose therapy can't be tolerable because of hemodynamic instability in the early stage of acute mycardial infarction(AMI). It is known that traditional Chinese medicine, compound Danshen dropping pills (CDDP) exerts protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and improves energy metabolism after acute myocardial ischemia. Experimental studies have shown CDDP may attenuate ventricular remodeling after myocardial infarction.
Methods:This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after acute anterior wall ST-Elevation MI(STEMI). 268 patients with acute anterior wall STEMI after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to CDDP group(n=134) and control group(n=134) with follow-up of 24 weeks. Both groups are treated with standard therapy of STEMI, with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets three times a day after pPCI and the control group treated with placebo at the same time. The primary endpoint is 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI).The secondary endpoint is the change in N terminal pro-B-type natriuretic peptide(NT-proBNP) level, arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).
Discussion:This is the first prospective study that will demonstrate the impact of CDDP on ventricular remodeling and cardiac function in patients treated with pPCI for a first acute anterior wall STEMI .This study may provide novel insights of Traditional Chinese Medicine , CDDP to improve ventricular remodeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Danshen Dropping Pills (CDDP) | Drug | The patients in this group are treated with 20 tablets of Compound Danshen Dropping Pills (CDDP) before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI. |
| Measure | Description | Time Frame |
|---|---|---|
| ultrasonic cardiogram:left ventricle ejection fraction (LVEF) | LVEF refers to the percentage of stroke output to left ventricular end-diastolic volume and it can be examined by ultrasonic cardiogram. | Week 24 |
| ultrasonic cardiogram:left ventricular end-diastolic volume index (LVEDVI) | LVEDVI(ml/m2)=left ventricular end-diastolic volume(ml)/body surface area(m2). It can be examined by ultrasonic cardiogram. | Week 24 |
| ultrasonic cardiogram:left ventricular end-systolic volume index (LVESVI) | LVESVI(ml/m2)=left ventricular end-systolic volume(ml)/body surface area(m2). It can be examined by ultrasonic cardiogram. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| N terminal pro-B-type natriuretic peptide(NT-proBNP )decline level | N terminal pro-B-type natriuretic peptide(NT-proBNP )is obtained by blood test. | Day 0/ Day 3/ Day 7/ Week 4/ Week 24/ Week 48 |
| Adverse cardiovascular events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liansheng Wang | Contact | +86 13390787111 | drlswang@njmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37656413 | Derived | Wu YJ, Deng B, Wang SB, Qiao R, Zhang XW, Lu Y, Wang L, Gu SZ, Zhang YQ, Li KQ, Yu ZL, Wu LX, Zhao SB, Zhou SL, Yang Y, Wang LS. 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. 2023 Dec;29(12):1059-1065. doi: 10.1007/s11655-023-3648-6. Epub 2023 Sep 1. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D020257 | Ventricular Remodeling |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Placebo | Drug | The patients in this group take 20 tablets of placebo before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI . |
|
| Day 0 to Week 48 |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D020763 | Pathological Conditions, Anatomical |