Intervention of compound Xueshuantong Capsule on the incidence of heart failure in patients with acute myocardial infarction after PCI based on the combination of disease and syndrome

Phase 4

Recruiting

• Conditions: Acute myocardial infarction

• Registration Number: ITMCTR1900002665
• Lead Sponsor: The First Affiliated Hospital of Guangzhou University of Chinese Medicine

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The patients with acute myocardial infarction within 12 hours, underwent emergency PCI, or underwent PCI after emergency thrombolytic therapy;
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. Stable angina or unstable angina;
2. Acute myocardial infarction with heart failure, Killip classification II, III or IV;
3. Acute myocardial infarction with severe complications, such as cardiogenic shock(conventional treatment cannot correct), or mechanical complication;
4. Severe arrhythmia, such as Rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.
5. Chronic heart failure or old myocardial infarction in the past medical history;
6. Combined with other diseases, such as cardiomyopathy, rheumatic heart disease, severe valvular heart disease, cardiac tamponade, hypertension emergency, pulmonary arterial hypertension, acute paroxysmal asthma /COPD, severe infection , and so on;
7. Patients with severe liver and kidney function impairment (ALT >3 times the upper limit of normal reference value, or Cr >= 3mg/dL or eGFR<= 60ml/min1.73m2); and with severe primary diseases such as endocrine or hematopoietic system; and with mental diseases;
8. Patients with malignant tumor;
9. Allergic constitution or allergy to multiple drug or food, allergy to known components of the study drugs;
10. Cannot take care of themselves and cannot receive oral drug;
11. Participated in other drug clinical trials within 3 month;
12. Suspecting or ensuring with a history of substance abuse alcohol or drug abuse;
13. Pregnant or lactating women, or planned pregnancy;
14. Patients with cerebral vascular accidents, major surgery and trauma recently.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
The Incidence of Heart failure;

Secondary Outcome Measures

Name	Time	Method
6-min walk test (6-MWT);hypersensitive C reactive protein;Echocardiography;traditional Chinese medicine(TCM) syndrome score;Major adverse cardiovascular events (MACEs);Minnesota questionnaire;type B natriuretic peptide(BNP);