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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03792035
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
fuwaihospital, China National Center for Cardiovascular Diseases

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: Tongxinluo Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.




Primary Outcome Measures :
  1. MACCE [ Time Frame: 30-day ]
    30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)


Secondary Outcome Measures :
  1. Revascularization [ Time Frame: 30-day ]
    Incidence of revascularization of the primary endpoints

  2. Cerebral stroke [ Time Frame: 30-day ]
    Incidence of cerebral stroke of the primary endpoints

  3. STEMI [ Time Frame: 30-day ]
    30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.

  4. The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V [ Time Frame: 30-day ]
    The incidence of bleeding in BARC(Bleeding Academic Research Committee Bleeding Standard) III and V at 30-day between 0-30%.

  5. MACCE [ Time Frame: 1 year ]
    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.

  6. In-stent restenosis [ Time Frame: 1 year ]
    1-year incidence of In-stent restenosis

  7. All-cause mortality rate at 1 year [ Time Frame: 1 year ]
    Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.

  8. Myocardial reperfusion and no-reflow [ Time Frame: 2 hours, 24 hours and 7 days ]
    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.


Other Outcome Measures:
  1. Total white cell count [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]
    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.

  2. Red blood cell [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]
    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.

  3. Hemoglobin [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]
    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.

  4. Blood platelet count [ Time Frame: 7 days, 1 month, 6 months and 1 year after medication ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03792035


Contacts
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Contact: Xiang-Dong Li, MD 13263138665 fuwai_lxd@163.com

Locations
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China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Xiangdong Li, MD         
Beijing Aerospace General Hospital Not yet recruiting
Beijing, Beijing, China, 100076
Contact: Dong-Nan Hu, MD         
Beijing Renhe Hospital Recruiting
Beijing, Beijing, China, 102600
Contact: Jixiang Ge, Dean    13716826088    ge-jx2004@163.com   
China, Hebei
Harrison International Peace Hospital Not yet recruiting
Hengshui, Hebei, China, 053000
Contact: Qun Zheng, MD         
China, Henan
Henan Provincial Peoples Hospital Not yet recruiting
Zhengzhou, Henan, China, 450003
Contact: Chuan-Yu Gao, MD         
China, Shandong
Taian City Central Hospital Not yet recruiting
Tai'an, Shandong, China, 271000
Contact: Huan-Yi Zhang, MD         
China, Tianjin
First Teaching Hospital of Tianjin University of TCM Not yet recruiting
Tianjin, Tianjin, China, 300193
Contact: Jing-Yuan Mao, MD         
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Investigators
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Principal Investigator: Yue-Jin Yang, MD Fuwai Hospital Chinese Academy of Medical Sciences

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Responsible Party: fuwaihospital, Assistant dean, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03792035    
Other Study ID Numbers: SP-YFC-03-CTS-AMI
2017YFC1700503 ( Other Grant/Funding Number: National Key R&D Program-Research ; Modernization of TCM )
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases