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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Tongxinluo
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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 [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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* tid, po.<br>|
| Placebo Comparator: Control group<br>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<br>* tid, po.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revascularization | Incidence of revascularization of the primary endpoints | 30-day | 
| Cerebral stroke | Incidence of cerebral stroke of the primary endpoints | 30-day | 
| STEMI | 30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias. | 30-day | 
| 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%. | 30-day | 
| 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. | 1 year | 
| In-stent restenosis | 1-year incidence of In-stent restenosis | 1 year | 
| All-cause mortality rate at 1 year | Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year. | 1 year | 
| 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. | 2 hours, 24 hours and 7 days |