Intervention of Acute Myocardial Infarction with integrated traditional Chinese Medicine and Western Medicine: a Randomized Controlled Trial.

Study on the prevention and treatment of atherosclerosis in Shandong Province with integrated traditional Chinese Medicine and Western Medicine-Intervention of Acute Myocardial Infarction with integrated traditional Chinese Medicine and Western Medicine

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003494

Enrollment

Unknown

Registered

2020-07-17

Start date

2021-07-15

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myocardial infarction

Interventions

Phlegm and blood stasis control group:placebo tablets (5 tablets each time, 3 times a day, starting within 5 days after PCI),placebo tablets have the same apperance with danlou tablets

Qi deficiency and blood stasis placebo group:placebo pills (starting within 5 days after PCI, oral 3 times a day, 0.5g each time),Placebo pills have the same apperance with qishenyiqi dripping pills

Qi deficiency and blood stasis treatment group:Qishen Yiqi dropping pills (starting within 5 days after PCI, oral 3 times a day, 0.5g each time)

Phlegm and blood stasis treatment group:Danlou tablets (5 tablets each time, 3 times a day, starting within 5 days after PCI)

Eligibility

Sex/Gender

All

Age

30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 30-75 years; (2) Patients with STEMI (cTnI peak > 99% URL) in emergency admission who meet the global definition of AMI (version 4) have a rise and fall curve, and have clinical evidence of myocardial ischemia. (see Annex 1 for detailed definition) (3) All patients had received emergency PCI, and TIMI blood flow classification of infarct related artery reached level 3 within 5 days after PCI; (4) Volunteered to participate in this study and informed consent has been signed.

Exclusion criteria

Exclusion criteria: (1) AMI with uncontrolled severe acute heart failure ; (2) AMI with cardiogenic shock (Killip grade >= I+II), no response to vasopressin; (3) AMI with severe arrhythmia (sustained ventricular tachycardia, ventricular fibrillation), atrioventricular block above grade II, and rapid atrial fibrillation; (4) AMI with mechanical complications (perforation of ventricular septum, rupture of papillary muscle, thrombus in cardiac cavity, rupture of free wall of ventricle); (5) Serious systemic diseases (serious infection, massive hemorrhage caused by anticoagulation and antithrombotic therapy, respiratory failure); (6) History of cerebral hemorrhage and cerebral aneurysm within 3 months; (7) Severe hepatic and renal insufficiency [ALT >= 3 ULN (upper limit of normal), Cr > 134 µ mol / L (2mg / dl) or EGFR < 45ml / min / 1.73m2]. (8) Patients with neuropsychiatric diseases; (9) Malignant tumor; (10) Other pathophysiological states with expected survival less than 1 year; (11) Those who are allergic to the ingredients of this study; (12) Pregnant or lactating women; (13) Patients who participated in other clinical studies of traditional Chinese medicine within three months before selection; (14) Other diseases with clinical significance may cause serious risks to patients.

Design outcomes

Primary

Measure	Time frame
LVESVi;LVEDVi;	—

Secondary

Measure	Time frame
Composite endpoint incidence of cardiovascular events;LVEF, E/e', LAV, GLS;cTnI, NT-proBNP, ST2;	—

Countries

China

Contacts

Public ContactYun Zhang

Qilu Hospital of Shandong University

zhangyun@sdu.edu.cn+86 13573102060

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026