China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
- Registration Number
- NCT03792035
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3796
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Tongxinluo 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 Control group Placebos 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
- Primary Outcome Measures
Name Time Method MACCE 30-day 30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)
- Secondary Outcome Measures
Name Time Method Revascularization 30-day Incidence of revascularization of the primary endpoints
Cerebral stroke 30-day Incidence of cerebral stroke of the primary endpoints
STEMI 30-day 30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias.
The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V 30-day The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%.
MACCE 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.
In-stent restenosis 1 year 1-year incidence of In-stent restenosis
All-cause mortality rate at 1 year 1 year Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year.
Myocardial reperfusion and no-reflow 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.
Trial Locations
- Locations (7)
Fuwai Hospital
🇨🇳Beijing, Beijing, China
Beijing Aerospace General Hospital
🇨🇳Beijing, Beijing, China
Beijing Renhe Hospital
🇨🇳Beijing, Beijing, China
Harrison International Peace Hospital
🇨🇳Hengshui, Hebei, China
Henan Provincial Peoples Hospital
🇨🇳Zhengzhou, Henan, China
Taian City Central Hospital
🇨🇳Tai'an, Shandong, China
First Teaching Hospital of Tianjin University of TCM
🇨🇳Tianjin, Tianjin, China