Status:
UNKNOWN
China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 safet...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
3796 Patients enrolled
Trial Details
Trial ID
NCT03792035
Start Date
May 23 2019
End Date
December 31 2021
Last Update
July 31 2019
Active Locations (7)
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1
Fuwai Hospital
Beijing, Beijing Municipality, China, 100037
2
Beijing Aerospace General Hospital
Beijing, Beijing Municipality, China, 100076
3
Beijing Renhe Hospital
Beijing, Beijing Municipality, China, 102600
4
Harrison International Peace Hospital
Hengshui, Hebei, China, 053000