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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,000
Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration
manual thrombus aspiration
Xijing hospital
Xi'an, Shaanxi, China
RECRUITINGDeath, Mayocardial infarction, NYHA Ⅳ heart failure
number of participants with death, mayocardial infarction or NYHA Ⅳ heart failure
Time frame: 1 year
Slow reflow/no reflow
number of participants with slow reflow/no reflow during PCI
Time frame: intraoperative
Left ventricular function
left ventricular ejection fraction evaluated by ultrasound and MRI
Time frame: 1 year
Seattle Angina Questionnaire scores
Seattle Angina Questionnaire scores
Time frame: 1 year
Canadian Cardiovascular Society (CCS) Functional Angina classification
Canadian Cardiovascular Society (CCS) Functional Angina classification
Time frame: 1 year
6-minute walk distance (6MWD)
6-minute walk distance (6MWD)
Time frame: 1 year
Stroke
number of participants with stroke
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.