China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
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.
Timeline
- Start
- 2019-05-23
- Primary completion
- 2021-09-30
- Completion
- 2021-12-31
Outcome
Met primary endpoint
paper Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group. PMID 37874574 ↗
paper risk difference [RD], -1.8% [95% CI, -3.2% to -0.6%]). PMID 37874574 ↗
paper significantly improved both 30-day and 1-year clinical outcomes. PMID 37874574 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tongxinluo | Traditional medicine (herbal / TCM) | 1.04 g | Oral |