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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Tongxinluo; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 3796
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiang-Dong Li, MD; Phone Number: 13263138665; Email: fuwai_lxd@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • Fuwai Hospital
      • Contact: Xiangdong Li, MD
    • Beijing, Beijing, China, 100076
      • Not yet recruiting
      • Beijing aerospace general hospital
      • Contact: Dong-Nan Hu, MD
    • Beijing, Beijing, China, 102600
      • Recruiting
      • Beijing Renhe Hospital
      • Contact: Jixiang Ge, Dean; Phone Number: 13716826088; Email: ge-jx2004@163.com
  • Hebei
    • Hengshui, Hebei, China, 053000
      • Not yet recruiting
      • Harrison International Peace Hospital
      • Contact: Qun Zheng, MD
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Not yet recruiting
      • Henan Provincial Peoples Hospital
      • Contact: Chuan-Yu Gao, MD
  • Shandong
    • Tai'an, Shandong, China, 271000
      • Not yet recruiting
      • Taian City Central Hospital
      • Contact: Huan-Yi Zhang, MD
  • Tianjin
    • Tianjin, Tianjin, China, 300193
      • Not yet recruiting
      • First Teaching Hospital of Tianjin University of TCM
      • Contact: Jing-Yuan Mao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year	Drug: Tongxinluo; tid, po.
Placebo Comparator: Control group; First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year	Drug: Placebos; tid, po.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revascularization	Incidence of revascularization of the primary endpoints	30-day
Cerebral stroke	Incidence of cerebral stroke of the primary endpoints	30-day
STEMI	30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.	30-day
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
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
In-stent restenosis	1-year incidence of In-stent restenosis	1 year
All-cause mortality rate at 1 year	Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.	1 year
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Yue-Jin Yang, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: January 1, 2019
• First Posted (Actual): January 3, 2019

Study Record Updates

• Last Update Posted (Actual): July 31, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: SP-YFC-03-CTS-AMI; 2017YFC1700503 (Other Grant/Funding Number: National Key R&D Program-Research ; Modernization of TCM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No