Trials / Unknown
UnknownNCT03792035
China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 3,796 (estimated)
- Sponsor
- China National Center for Cardiovascular Diseases · Other Government
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tongxinluo | tid, po. |
| DRUG | Placebos | tid, po. |
Timeline
- Start date
- 2019-05-23
- Primary completion
- 2021-09-30
- Completion
- 2021-12-31
- First posted
- 2019-01-03
- Last updated
- 2019-07-31
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03792035. Inclusion in this directory is not an endorsement.