An interventional study of Nitroprusside Sodium and Tirofiban Hydrochloride in ST Segment Elevation Myocardial Infarction and Primary Percutaneous Coronary Intervention, sponsored by The First Affiliated Hospital of Zhengzhou University. Status unknown at 28 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Not applicable, Interventional, and Prevention
Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.
Exclusion Criteria:
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Nitroprusside Sodium via guide-catheter was performed. Then repeated administration of Nitroprusside Sodium was done prior to coronary stent implantation or post dilatation.
Drug: Nitroprusside Sodium
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of Tirofiban Hydrochloride via guide-catheter was performed.
Drug: Tirofiban Hydrochloride
After coronary target vessel blood flow recovery by thrombus aspiration or/and balloon angioplasty (diameter ≤ 2.0mm), intracoronary infusion of heparinized saline via guide-catheter was performed.
Drug: Heparinized saline
Intracoronary infusion 50\~100μg each time (repeated)
Also known as: Experimental-1 group
Intracoronary infusion 10μg/kg for single time
Also known as: Experimental-2 group
Intracoronary infusion 2ml for single time
Also known as: Control group
Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation
Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.
Time frame: 1 minute after stent implantation
Coronary artery flow using TIMI flow grade after balloon dilatation
Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery.
Time frame: 1 minute after balloon dilatation
Coronary TIMI frame count after stent implantation
A continuous measurement assessing flow in the epicardial arteries.
Time frame: 1 minute after stent implantation
Coronary TIMI frame count after balloon dilatation
A continuous measurement assessing flow in the epicardial arteries.
Time frame: 1 minute after balloon dilatation
Slow flow / no-reflow phenomenon after stent implantation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Time frame: 1 minute after stent implantation
Slow flow / no-reflow phenomenon after balloon dilatation
Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree.
Time frame: 1 minute after balloon dilatation
ECG ST-segment fall more than 50%
The extent of ST segment elevation was reduced by more than 50%
Time frame: in 2 hours post-PCI
Main adverse cardiovascular and cerebrovascular events (MACCE)
Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc.
Time frame: at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI
Plan to share: No
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The First Affiliated Hospital of Zhengzhou University