A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Anfibatide is a snake venom, and we have investigated it in humans for many years with phase 1\&2a studies. A Phase IIb clinical trial to investigate the safety and efficacy of antiplatelet thrombolysin injection for patients with ST Segment Elevation Myocardial Infarction (STEMI) before receiving PCI therapy, in order to provide evidence for Phase III design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Freeze-dried powder without snake venom will be dissovled in saline
Freeze-dried powder with snake venom will be dissovled in saline
Peking University First hospiatl
Beijing, China
ratio of TMPG grade 2 and grade 3
After PCI, TMPG grade will be evaluated and
Time frame: within 24 hours
inhibition rate of platelet aggregation and GP1b receptor combination rate
Baseline, 15-20 minutes after injection, 24-26 hours after injection, 48-50 hours after injection, 8-10 hours after the cease of medication, the comment and analysis of the inhibition rate of platelet aggregation and GP1b receptor combination rate
Time frame: 48 hours
Patients ratio of no-reflow to slow-flow in coronary artery after PCI therapy
Time frame: 24 hours
Analysis of iconography reference: instant TIMI, CTFC and TMPG before/after the target vessel revascularization PCI therapy
Time frame: 24 hours
The depression level of ST segment from right after the PCI therapy to 2 hours later
i. Complete: depression level ≥ 70% ii. Partially: 30% ≤ depression level \< 70% iii. None: \< 30%
Time frame: within 24 hours
Compare the baseline troponin level to the troponin level at 24-26 hours after injection and at 3 days after the surgery respectively
Time frame: 72 hours
(6) Check the CMR at 3-5 days after the surgery, evaluate the Myocardium Salvage Index (MSI)
Time frame: 5 days
(7) While surgery and hospitalization, follow the ratio and dose as suggested by the surgeon in case of emergency use of GP IIb/IIIa receptor antagonist or other antiplatelet drug
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Time frame: 5 days
(8) Clinical endpoint 30 days after surgery (caused by death, non-fatal myocardial infarction reissue, blood clot formation after stent implantation, non-fatal stroke, target lesion revascularization reissue) and the analysis of the causes
Time frame: 30days
Recorded hemorrhage issues for 30 days after the surgery (BARC hemorrhage standard)
Time frame: 30days