Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction patients
1. This study is a phase Ib-IIa exploratory study to observe the safety of Antiplatelet Thrombolysin for Injection for the treatment of non-ST segment myocardial infarction (NSTEMI) patients and preliminarily evaluate the efficacy of different doses, providing the theoretical basis of the phase II and III clinical study protocol. 2. To investigate the pharmacokinetics of different doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Snake venom
Saline
Peking University First hospiatl
Beijing, China
Platelet aggregation
The inhibition of ristocetin-induced platelet aggregation as measured by whole blood impedance aggregometr in vitro.
Time frame: up to 48 hours
Bleeding events
Bleeding events classified according to the Bleeding Academic Research Consortium (BARC) .
Time frame: Day 0 to day 30
Mortality
all-cause mortality, relapse of nonfatal myocardial infarction, nonfatal stroke, second target vascular reconstructio.
Time frame: 30 days after treatment
Safety Endpoints
Degree of thrombocytopenia; Moderate (\<100,000 platelets/mm3); Severe (\<50,000 platelets/mm3); Extremely severe (\<20,000 platelets/mm3)
Time frame: Day 0 to day 30
Thrombosis formation
Thrombosis formation after stent implantation:
Time frame: 48 hours after infusion during operation
Thrombolysis in myocardial infraction (TIMI)
The proportion of TIMI from grade 0 to 3 Pre -and post-PCI was evaluated.
Time frame: day 0
Corrected TIMI frame count(CTFC)
The values of CTFC were evaluated and compared between groups.
Time frame: day 0
TIMI myocardial perfusion grade (TMBG)
The proportion of TMPG from grade 0 to 3 Pre -and post-PCI was evaluated.
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Time frame: day 0