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

Primary Purpose

Acute Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tongxinluo
Placebos
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuwai HospitalRecruiting
  • Beijing Aerospace General Hospital
  • Beijing Renhe HospitalRecruiting
  • Harrison International Peace Hospital
  • Henan Provincial Peoples Hospital
  • Taian City Central Hospital
  • First Teaching Hospital of Tianjin University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

MACCE
30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)

Secondary Outcome Measures

Revascularization
Incidence of revascularization of the primary endpoints
Cerebral stroke
Incidence of cerebral stroke of the primary endpoints
STEMI
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
The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%.
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.
In-stent restenosis
1-year incidence of In-stent restenosis
All-cause mortality rate at 1 year
Symptoms improved after treatment. Evaluate all-cause mortality rate at 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.

Full Information

First Posted
December 3, 2018
Last Updated
July 30, 2019
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT03792035
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3796 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Tongxinluo
Intervention Description
tid, po.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
tid, po.
Primary Outcome Measure Information:
Title
MACCE
Description
30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)
Time Frame
30-day
Secondary Outcome Measure Information:
Title
Revascularization
Description
Incidence of revascularization of the primary endpoints
Time Frame
30-day
Title
Cerebral stroke
Description
Incidence of cerebral stroke of the primary endpoints
Time Frame
30-day
Title
STEMI
Description
30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.
Time Frame
30-day
Title
The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V
Description
The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%.
Time Frame
30-day
Title
MACCE
Description
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.
Time Frame
1 year
Title
In-stent restenosis
Description
1-year incidence of In-stent restenosis
Time Frame
1 year
Title
All-cause mortality rate at 1 year
Description
Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.
Time Frame
1 year
Title
Myocardial reperfusion and no-reflow
Description
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.
Time Frame
2 hours, 24 hours and 7 days
Other Pre-specified Outcome Measures:
Title
Total white cell count
Description
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.
Time Frame
7 days, 1 month, 6 months and 1 year after medication
Title
Red blood cell
Description
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.
Time Frame
7 days, 1 month, 6 months and 1 year after medication
Title
Hemoglobin
Description
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.
Time Frame
7 days, 1 month, 6 months and 1 year after medication
Title
Blood platelet count
Description
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.
Time Frame
7 days, 1 month, 6 months and 1 year after medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age>18 years; Within 24 hours of infarctional chest pain onset; ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB); Voluntary participation in the study with consent forms signed. Exclusion Criteria: Critically illness due to STEMI; Long-term (>20 min) cardio-pulmonary resuscitation (CPR); Suspected aortic dissection or acute pulmonary embolism; Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls. Serious cardiogenic shock and do not responding to hypertensive agents; Uncontrolled acute left heart failure or pulmonary edema; Malignant arrhythmias uncontrolled by anti-arrhythmia agents; Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month; Presence of active hemorrhage at any part of the body (including menstruation); Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders; Current usage of anticoagulants (such as Warfarin or new anticoagulants); . Serious hepatorenal dysfunction [ATL≥5 ULN (upper limit of normal), Cr>134μmol/L (2mg%) or eGFR<45ml/min/1.73m2]; Serious chronic obstructive pulmonary disease (COPD) or respiratory failure; . Severe infection: . Very weak or frailty; . Neuropsychiatric system diseases; . Malignancies; . Other pathophysiological conditions with expected survival time <1 year; Allergy to the ingredients of this investigational drug; Women who are in pregnancy or nursery; Participation in clinical study of other traditional Chinese medicine (TCM); Unsuitability to participate in this study due to other diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiang-Dong Li, MD
Phone
13263138665
Email
fuwai_lxd@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yue-Jin Yang, MD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangdong Li, MD
Facility Name
Beijing Aerospace General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100076
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Nan Hu, MD
Facility Name
Beijing Renhe Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102600
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jixiang Ge, Dean
Phone
13716826088
Email
ge-jx2004@163.com
Facility Name
Harrison International Peace Hospital
City
Hengshui
State/Province
Hebei
ZIP/Postal Code
053000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Zheng, MD
Facility Name
Henan Provincial Peoples Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuan-Yu Gao, MD
Facility Name
Taian City Central Hospital
City
Tai'an
State/Province
Shandong
ZIP/Postal Code
271000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huan-Yi Zhang, MD
Facility Name
First Teaching Hospital of Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300193
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Yuan Mao, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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