China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
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.