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

• ClinicalTrials.gov Identifier: NCT03792035
• Recruitment Status: Unknown
• First Posted: January 3, 2019
• Last Update Posted: July 31, 2019
• Sponsor: China National Center for Cardiovascular Diseases
• Information provided by (Responsible Party): fuwaihospital, China National Center for Cardiovascular Diseases

Tracking Information

• First Submitted Date: December 3, 2018
• First Posted Date: January 3, 2019
• Last Update Posted Date: July 31, 2019
• Actual Study Start Date: May 23, 2019
• Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 1, 2019)

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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 1, 2019)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: January 1, 2019)

• 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.
• 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.
• 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.
• 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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acute Myocardial Infarction

Intervention

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

Study Arms

• 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
  Intervention: Drug: Tongxinluo
• 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
  Intervention: Drug: Placebos

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 1, 2019): 3796
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2021
• Estimated Primary Completion Date: September 30, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03792035
• Other Study ID Numbers: SP-YFC-03-CTS-AMI; 2017YFC1700503 ( Other Grant/Funding Number: National Key R&D Program-Research ; Modernization of TCM )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: fuwaihospital, China National Center for Cardiovascular Diseases
• Original Responsible Party: Same as current
• Current Study Sponsor: China National Center for Cardiovascular Diseases
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Yue-Jin Yang, MD; Chinese Academy of Medical Sciences, Fuwai Hospital

• PRS Account: China National Center for Cardiovascular Diseases
• Verification Date: July 2019