Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty

Study Overview
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Brief Summary
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This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.

Detailed Description
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This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Official Title
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Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty

Conditions
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ST-elevation Myocardial Infarction

Intervention / Treatment
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* Drug: cocktail
* Device: thrombus aspiration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset Exclusion Criteria: Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocktail with thrombus aspiration<br>Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration | Drug: cocktail<br>* Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration<br>* Other names: tirofiban, bivalirudin, tenecteplase;Device: thrombus aspiration<br>* manual thrombus aspiration<br>* Other names: manual thrombus aspiration;|
| Active Comparator: Thrombus aspiration<br>Thrombus aspiration alone | Device: thrombus aspiration<br>* manual thrombus aspiration<br>* Other names: manual thrombus aspiration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, Mayocardial infarction, NYHA Ⅳ heart failure | number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slow reflow/no reflow | number of participants with slow reflow/no reflow during PCI | intraoperative | 
| Left ventricular function | left ventricular ejection fraction evaluated by ultrasound and MRI | 1 year | 
| Seattle Angina Questionnaire scores | Seattle Angina Questionnaire scores | 1 year | 
| Canadian Cardiovascular Society (CCS) Functional Angina classification | Canadian Cardiovascular Society (CCS) Functional Angina classification | 1 year | 
| 6-minute walk distance (6MWD) | 6-minute walk distance (6MWD) | 1 year | 
| Stroke | number of participants with stroke | 1 year |