Sequential intervention of xinGengSanFang granule in patients with acute ST segment elevation myocardial infarction: a randomized, controlled, open label, multicenter clinical trial

Phase 1

• Conditions: acute ST segment elevation myocardial infarction

• Registration Number: ITMCTR2200005629
• Lead Sponsor: Guang'anmen Hospital, Chinese Academy of traditional 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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a)Aged 18 years or over and under 85 years
b)Presence of STEMI who has successfully coronary recanalization by PCI within 12 h after the symptom onset;
c)Willingness to provide informed consent prior to enrollment;

Exclusion Criteria

a)Blood pressure control is not ideal, systolic blood pressure exceeds 180mmHg or diastolic blood pressure exceeds 110mmHg.
b)Critical condition or CPR>20 min.
c)Explicit mechanical complications, including perforation of ventricular septum, rupture of papillary muscle and tendon, or rupture of left ventricular free wall.
d)Uncontrolled acute left heart failure or pulmonary edema, and severe cardiogenic shock.
e)Malignant arrhythmia beyond the control of antiarrhythmic drugs.
f)Bleeding history of cerebrol vessels,gastrointestinal tract,respiratory tract,urinary tract,or other organs wothin 1 m.
g)Presence of active hemorrhage at any part of the body(not including menstruation),and known hemorrhagic constitution or serious hemostasis and blood coagulation disorders.
h)Malignant tumors or other life-threatening diseases with limited life expectancy <0.5 year.
i)Significant neuropsychopathic condition.
j)Pregnant and lactating women.
k)Allergic to the experimental drug ingredients.
l)Currently participating in other traditional Chinese medicine experiments.
m)Renal insufficiency (glomerular filtration rate=30 mL/min per 1.73 m2 or Serum creatinine>176.8umol/L.)
n)Serious hepatic dysfunction.(ALT=5ULN)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
VEF;LVEDV;LVESV;