ST-elevation Myocardial Infarction
Conditions
Brief summary
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
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.
Interventions
DRUGcocktail
Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration
DEVICEthrombus aspiration
manual thrombus aspiration
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death, Mayocardial infarction, NYHA Ⅳ heart failure | 1 year | number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular function | 1 year | left ventricular ejection fraction evaluated by ultrasound and MRI |
| Seattle Angina Questionnaire scores | 1 year | Seattle Angina Questionnaire scores |
| Slow reflow/no reflow | intraoperative | number of participants with slow reflow/no reflow during PCI |
| 6-minute walk distance (6MWD) | 1 year | 6-minute walk distance (6MWD) |
| Stroke | 1 year | number of participants with stroke |
| Canadian Cardiovascular Society (CCS) Functional Angina classification | 1 year | Canadian Cardiovascular Society (CCS) Functional Angina classification |
Countries
China
Contacts
Primary ContactDongdong Sun, M.D.,Ph.D.
Outcome results
None listed