The Impact of Compound Danshen Dropping Pills (CDDP) on the Post-myocardial Infarction Ventricular Remodeling

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

1. Aged 18-75 years, gender unlimited;

2. According to the guidelines for diagnosis and treatment of acute ST segment elevation myocardial infarction (2019), patients with acute anterior ST segment elevation myocardial infarction were diagnosed;

3. Patients with primary acute myocardial infarction;

4. Patients who completed PCI reperfusion treatment within 12 hours after the onset of the disease;

5. Subjects participated in the study voluntarily and signed informed consent.

Exclusion Criteria:

1. Patients with previous cardiac insufficiency caused by other diseases (valvular heart disease, congenital heart disease, pericardial disease, arrhythmia, other non cardiac causes);

2. The patients underwent coronary artery bypass graft（CABG） within 12 weeks;

3. Patients undergoing cardiac resynchronization;

4. Patients with left ventricular outflow tract obstruction;

5. Patients with myocarditis;

6. Patients with uncontrolled severe arrhythmia;

7. Patients with aortic aneurysm;

8. Patients with serious liver, kidney, blood system, mental disease or systemic disease;

9. Significant liver and kidney dysfunction (ALT > 2.0 times the upper limit of normal value; creatinine > 1.5 times the upper limit of normal value);

10. Patients with serum potassium > 5.5mmol/l;

11. Uncontrolled hypertension (higher than 180 / 110mmhg);

12. Pregnant or lactating women;

13. Patients allergic to compound Danshen Dropping Pills; 1

14. Patients participating in clinical studies of other drugs.