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

July 30, 2019 updated by: fuwaihospital, China National Center for Cardiovascular Diseases
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3796

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
30-day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Revascularization
Time Frame: 30-day
Incidence of revascularization of the primary endpoints
30-day
Cerebral stroke
Time Frame: 30-day
Incidence of cerebral stroke of the primary endpoints
30-day
STEMI
Time Frame: 30-day
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
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%.
30-day
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.
1 year
In-stent restenosis
Time Frame: 1 year
1-year incidence of In-stent restenosis
1 year
All-cause mortality rate at 1 year
Time Frame: 1 year
Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.
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.
2 hours, 24 hours and 7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
7 days, 1 month, 6 months and 1 year after medication
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.
7 days, 1 month, 6 months and 1 year after medication
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.
7 days, 1 month, 6 months and 1 year after medication
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.
7 days, 1 month, 6 months and 1 year after medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yue-Jin Yang, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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