To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3,796
tid, po.
tid, po.
Fuwai Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Aerospace General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Renhe Hospital
Beijing, Beijing Municipality, China
RECRUITINGHarrison International Peace Hospital
Hengshui, Hebei, China
NOT_YET_RECRUITINGHenan Provincial Peoples Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGTaian City Central Hospital
Tai’an, Shandong, China
NOT_YET_RECRUITINGFirst Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITINGMACCE
30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)
Time frame: 30-day
Revascularization
Incidence of revascularization of the primary endpoints
Time frame: 30-day
Cerebral stroke
Incidence of cerebral stroke of the primary endpoints
Time frame: 30-day
STEMI
30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.
Time frame: 30-day
The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V
The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V at 30-day between 0-30%.
Time frame: 30-day
MACCE
1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event.
Time frame: 1 year
In-stent restenosis
1-year incidence of In-stent restenosis
Time frame: 1 year
All-cause mortality rate at 1 year
Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.
Time frame: 1 year
Myocardial reperfusion and no-reflow
Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy.
Time frame: 2 hours, 24 hours and 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.