Clinical trial NCT03792035: China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Official title: China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2019-01-03
Enrollment: 3796
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age\>18 years;
2. Within 24 hours of infarctional chest pain onset;
3. ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB);
4. Voluntary participation in the study with consent forms signed.

Exclusion Criteria:

1. Critically illness due to STEMI;
2. Long-term (\>20 min) cardio-pulmonary resuscitation (CPR);
3. Suspected aortic dissection or acute pulmonary embolism;
4. Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls.
5. Serious cardiogenic shock and do not responding to hypertensive agents;
6. Uncontrolled acute left heart failure or pulmonary edema;
7. Malignant arrhythmias uncontrolled by anti-arrhythmia agents;
8. Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month;
9. Presence of active hemorrhage at any part of the body (including menstruation);
10. Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;
11. Current usage of anticoagulants (such as Warfarin or new anticoagulants);
12. . Serious hepatorenal dysfunction \[ATL≥5 ULN (upper limit of normal), Cr\>134μmol/L (2mg%) or eGFR\<45ml/min/1.73m2\];
13. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;
14. . Severe infection:
15. . Very weak or frailty;
16. . Neuropsychiatric system diseases;
17. . Malignancies;
18. . Other pathophysiological conditions with expected survival time \<1 year;
19. Allergy to the ingredients of this investigational drug;
20. Women who are in pregnancy or nursery;
21. Participation in clinical study of other traditional Chinese medicine (TCM);
22. Unsuitability to participate in this study due to other diseases.

Primary outcomes:
measure: MACCE
timeFrame: 30-day
Secondary outcomes:
measure: Revascularization
timeFrame: 30-day
measure: Cerebral stroke
timeFrame: 30-day
measure: STEMI
timeFrame: 30-day
measure: The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V
timeFrame: 30-day
measure: MACCE
timeFrame: 1 year
measure: In-stent restenosis
timeFrame: 1 year
measure: All-cause mortality rate at 1 year
timeFrame: 1 year
measure: Myocardial reperfusion and no-reflow
timeFrame: 2 hours, 24 hours and 7 days
Other outcomes:
measure: Total white cell count
timeFrame: 7 days, 1 month, 6 months and 1 year after medication
measure: Red blood cell
timeFrame: 7 days, 1 month, 6 months and 1 year after medication
measure: Hemoglobin
timeFrame: 7 days, 1 month, 6 months and 1 year after medication
measure: Blood platelet count
timeFrame: 7 days, 1 month, 6 months and 1 year after medication
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Aerospace General Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Renhe Hospital
state: Beijing
city: Hengshui
country: China
facility: Harrison International Peace Hospital
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial Peoples Hospital
state: Henan
city: Tai'an
country: China
facility: Taian City Central Hospital
state: Shandong
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of TCM
state: Tianjin
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yue-Jin Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: