NCT03792035

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,796

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2019

Typical duration for phase_4

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 3, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

December 3, 2018

Last Update Submit

July 30, 2019

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Revascularization

    30-day

  • Cerebral stroke

    30-day

  • STEMI

    30-day

  • The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V

    30-day

  • MACCE

    1 year

  • +3 more secondary outcomes

Other Outcomes (4)

  • Total white cell count

    7 days, 1 month, 6 months and 1 year after medication

  • Red blood cell

    7 days, 1 month, 6 months and 1 year after medication

  • Hemoglobin

    7 days, 1 month, 6 months and 1 year after medication

  • +1 more other outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

TongxinluoDRUG

tid, po.

Experimental group
PlacebosDRUG

tid, po.

Control group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Beijing Aerospace General Hospital

Beijing, Beijing Municipality, 100076, China

NOT YET RECRUITING

Beijing Renhe Hospital

Beijing, Beijing Municipality, 102600, China

RECRUITING

Harrison International Peace Hospital

Hengshui, Hebei, 053000, China

NOT YET RECRUITING

Henan Provincial Peoples Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Taian City Central Hospital

Tai’an, Shandong, 271000, China

NOT YET RECRUITING

First Teaching Hospital of Tianjin University of TCM

Tianjin, Tianjin Municipality, 300193, China

NOT YET RECRUITING

Related Publications (1)

  • Yang Y, Li X, Chen G, Xian Y, Zhang H, Wu Y, Yang Y, Wu J, Wang C, He S, Wang Z, Wang Y, Wang Z, Liu H, Wang X, Zhang M, Zhang J, Li J, An T, Guan H, Li L, Shang M, Yao C, Han Y, Zhang B, Gao R, Peterson ED; CTS-AMI Investigators. Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction: The CTS-AMI Randomized Clinical Trial. JAMA. 2023 Oct 24;330(16):1534-1545. doi: 10.1001/jama.2023.19524.

    PMID: 37874574DERIVED

MeSH Terms

Interventions

tongxinluo

Study Officials

  • Yue-Jin Yang, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiang-Dong Li, MD

CONTACT

13263138665fuwai_lxd@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant dean

Study Record Dates

First Submitted

December 3, 2018

First Posted

January 3, 2019

Study Start

May 23, 2019

Primary Completion

September 30, 2021

Study Completion

December 31, 2021

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)