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

NCT05000411 | Unknown Phase 4

• 1 other identifier: CDDP
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Ventricular Remodeling; CDDP

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level

  Day 0/ Day 3/ Day 7/ Week 4/ Week 24/ Week 48

• Adverse cardiovascular events

  Day 0 to Week 48

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Compound Danshen Dropping Pills (CDDP)

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Experimental group

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 .

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, gender unlimited;
• 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;
• Patients with primary acute myocardial infarction;
• Patients who completed PCI reperfusion treatment within 12 hours after the onset of the disease;
• Patients categorized as Classes I, II or III according to Killip classification on admission;
• Subjects participated in the study voluntarily and signed informed consent.

You may not qualify if:

• Patients with previous cardiac insufficiency caused by other diseases (valvular heart disease, congenital heart disease, pericardial disease, arrhythmia, other non cardiac causes);
• The patients underwent coronary artery bypass graft（CABG） within 12 weeks;
• Patients undergoing cardiac resynchronization;
• Patients with left ventricular outflow tract obstruction;
• Patients with myocarditis;
• Patients with uncontrolled severe arrhythmia;
• Patients with aortic aneurysm;
• Patients with serious liver, kidney, blood system, mental disease or systemic disease;
• 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);
• Patients with serum potassium \> 5.5mmol/l;
• Uncontrolled hypertension (higher than 180 / 110mmhg);
• Pregnant or lactating women;
• Patients allergic to compound Danshen Dropping Pills; 1
• Patients participating in clinical studies of other drugs.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37656413 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Ventricular Remodeling

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Pathological Conditions, Anatomical

Central Study Contacts

Liansheng Wang

CONTACT

+86 13390787111; drlswang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 11, 2021
• Study Start: August 25, 2021
• Primary Completion: August 25, 2023
• Study Completion: March 1, 2024
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

CN (1)