Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03792035
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2018-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Sponsor:
China National Center for Cardiovascular Diseases
Organization:
Study Overview
Official Title:
China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017YFC1700503 | OTHER_GRANT | National Key R&D Program-Research ; Modernization of TCM | View |