Study for Tong-Mai Yang-Xin pill for delaying the myocardial reconstruction after PCI operation of coronary heart disease

Phase 4

• Conditions: Coronary heart disease (CHD)

• Registration Number: ITMCTR1900002321
• Lead Sponsor: The First Affiliated Hospital of He'nan University of CM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The patients with acute anterior myocardial infarction within 10 days, underwent emergency PCI, or underwent PCI after emergency thrombolytic therapy, or received elective PCI within 10 days;
2. The patients meet the syndrome differentiation standard of TCM with Deficient Qi and Yin combined blood stasis;
3. Aged 18 to 75 years, both men and women;
4. Sign the informed consent voluntarily.

Exclusion Criteria

1. The patients with Multiple coronary artery branches lesions didnt receive elective PCI within 10 days;
2. Acute myocardial infarction with severe complications, such as acute heart failure, cardiogenic shock(conventional treatment cannot correct), or mechanical complication;
3. Acute myocardial infarction with heart failure, Killip classification III or IV;
4. Chronic heart failure or old anterior myocardial infarction in the past medical history;
5. Combined with other diseases, such as cardiomyopathy, rheumatic heart disease, valvular heart disease (Severe stenosis/incomplete closure), arrhythmia (persistent atrial fibrillation/atrial flutter, third degree a-v block, sick sinus syndrome, after implantation of pacemaker) hyperthyroidism, cardiac tamponade, pulmonary arterial hypertensionacute paroxysmal asthma/COPD, severe infection , and so on;
6. Patients with severe liver and kidney function impairment (ALT, AST or TBIL>3 times the upper limit of normal reference value, or Cr >=3mg/dL or eGFR=60ml/min1.73m2); and with severe primary diseases or mental diseases such as hematopoietic system;
7. Patients with malignant tumor;
8. Allergic constitution or allergy to multiple drug or food, allergy to known components of the study drugs;
9. Cannot take care of themselves and cannot receive oral drug;
10. Participated in other drug clinical trials within 1 month;
11. Suspecting or ensuring with a history of substance abuse alcohol or drug abuse;
12. Pregnant or lactating women, or planned pregnancy;
13. According to the judgment of the researcher, the subject is not suitable for involving.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
left ventricular end-diastolic volume index;

Secondary Outcome Measures

Name	Time	Method
T-proBNP;Revascularization;Cardiovascular related hospitalization;Cardiovascular related deaths;Chinese medicine symptom complex score;Echocardiography;Seattle angina scale score;Ambulatory ECG;biological indicator;six-minute walk test;cardiac magnetic resonance imagingCMRI;