China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03792035
• Other study ID #: SP-YFC-03-CTS-AMI
• Secondary ID: 2017YFC1700503
• Status: Recruiting
• Phase: Phase 4
• Start date: May 23, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: China National Center for Cardiovascular Diseases
• Contact: Xiang-Dong Li, MD
• Phone: 13263138665
• Email: fuwai_lxd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3796
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Tongxinluo
tid, po.
• Placebos
tid, po.

Locations

Country	Name	City	State
China	Beijing Aerospace General Hospital	Beijing	Beijing
China	Beijing Renhe Hospital	Beijing	Beijing
China	Fuwai Hospital	Beijing	Beijing
China	Harrison International Peace Hospital	Hengshui	Hebei
China	Taian City Central Hospital	Tai'an	Shandong
China	First Teaching Hospital of Tianjin University of TCM	Tianjin	Tianjin
China	Henan Provincial Peoples Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total white cell count	Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.	7 days, 1 month, 6 months and 1 year after medication
Other	Red blood cell	Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.	7 days, 1 month, 6 months and 1 year after medication
Other	Hemoglobin	Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.	7 days, 1 month, 6 months and 1 year after medication
Other	Blood platelet count	Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range.	7 days, 1 month, 6 months and 1 year after medication
Primary	MACCE	30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)	30-day
Secondary	Revascularization	Incidence of revascularization of the primary endpoints	30-day
Secondary	Cerebral stroke	Incidence of cerebral stroke of the primary endpoints	30-day
Secondary	STEMI	30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.	30-day
Secondary	The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V	The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V at 30-day between 0-30%.	30-day
Secondary	MACCE	1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event.	1 year
Secondary	In-stent restenosis	1-year incidence of In-stent restenosis	1 year
Secondary	All-cause mortality rate at 1 year	Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.	1 year
Secondary	Myocardial reperfusion and no-reflow	Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy.	2 hours, 24 hours and 7 days