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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail with thrombus aspiration | Experimental | Intracoronary cocktail (tirofiban, bivalirudin, tenecteplase) injection combined with thrombus aspiration |
|
| Thrombus aspiration | Active Comparator | Thrombus aspiration alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cocktail | Drug | Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death, Mayocardial infarction, NYHA â…£ heart failure | number of participants with death, mayocardial infarction or NYHA â…£ heart failure | 1 year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongdong Sun, M.D.,Ph.D. | Contact | 86 29 84775183 | wintersun3@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongdong Sun, M.D.,Ph.D. | Air Force Military Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077466 | Tirofiban |
| C074619 | bivalirudin |
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| thrombus aspiration | Device | manual thrombus aspiration |
|
|
| 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 |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |