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Acute Myocardial InfarctionPhase 4NCT03792035

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

A Phase 4 study testing Tongxinluo in people with Acute Myocardial Infarction, run by China National Center for Cardiovascular Diseases at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Tongxinluo
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,796 participants
Where
7 sitesChina
Study dates
23 May 2019to 31 Dec 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 22Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country.

Xiang-Dong Li, MD contact

13263138665

fuwai_lxd@163.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

    Xiangdong Li, MD

    Recruiting

  • Beijing Aerospace General Hospital

    Beijing, Beijing Municipality, 100076

    Dong-Nan Hu, MD

    Not yet recruiting

  • Beijing Renhe Hospital

    Beijing, Beijing Municipality, 102600

    Jixiang Ge, Dean, 13716826088, ge-jx2004@163.com

    Recruiting

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

    Qun Zheng, MD

    Not yet recruiting

  • Taian City Central Hospital

    Tai’an, Shandong, 271000

    Huan-Yi Zhang, MD

    Not yet recruiting

  • First Teaching Hospital of Tianjin University of TCM

    Tianjin, Tianjin Municipality, 300193

    Jing-Yuan Mao, MD

    Not yet recruiting

  • Henan Provincial Peoples Hospital

    Zhengzhou, Henan, 450003

    Chuan-Yu Gao, MD

    Not yet recruiting

Other trials in China

About this study

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.

Being tested
Tongxinluo, Placebos

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TongxinluoDrug

    tid, po.

  • PlacebosDrug

    tid, po.

Study groups in NCT03792035
Study groupRoleWhat they receive
Experimental groupExperimentalFirst time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
Receives: Drug: Tongxinluo
Control groupPlacebo comparatorFirst time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACCE

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

    Measured: 30-day

Secondary outcomes (8)

  1. Revascularization

    Incidence of revascularization of the primary endpoints

    Measured: 30-day

  2. Cerebral stroke

    Incidence of cerebral stroke of the primary endpoints

    Measured: 30-day

  3. STEMI

    30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.

    Measured: 30-day

  4. 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%.

    Measured: 30-day

  5. 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.

    Measured: 1 year

  6. In-stent restenosis

    1-year incidence of In-stent restenosis

    Measured: 1 year

  7. All-cause mortality rate at 1 year

    Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.

    Measured: 1 year

  8. 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.

    Measured: 2 hours, 24 hours and 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2019
  2. Study start23 May 2019
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,796 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03792035
Sponsor's protocol ID
SP-YFC-03-CTS-AMI
Other IDs
2017YFC1700503
Status last verified
Jul 2019
First submitted
3 Dec 2018
Last updated
31 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37874574

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tongxinluo in people with Acute Myocardial Infarction, run by China National Center for Cardiovascular Diseases at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiang-Dong Li, MD (13263138665, fuwai_lxd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACCE (time frame: 30-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792035, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.

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