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

  • STATUS
    Recruiting
  • days left to enroll
    35
  • participants needed
    3796
  • sponsor
    China National Center for Cardiovascular Diseases
Updated on 24 January 2021
chest pain
stroke
heart failure
stemi
bundle branch block

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.

Details
Condition Acute Myocardial Infarction
Treatment placebos, Tongxinluo
Clinical Study IdentifierNCT03792035
SponsorChina National Center for Cardiovascular Diseases
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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 [ATL5 ULN (upper limit of normal), Cr>134mol/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
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