Results of a pilot clinical trial of the safety and efficacy of an original glycoprotein IIb/IIIa receptor inhibitor in acute coronary syndrome







https://doi.org/10.15829/1728-8800-2023-3573
EDN: LPEYHH
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Abstract
Aim. To study the safety and efficacy of Angipure in acute ST-segment elevation coronary syndrome (STE-ACS) and high-risk percutaneous transluminal coronary angioplasty (PTCA) compared with eptifibatide.
Material and methods. The study included 157 patients with STE-ACS. High-risk PTCA included massive or total coronary artery thrombosis, noreflow/slow-reflow phenomenon, and acute stent thrombosis. Fifty-five people received Angipure at a dose of 0,72 mg/kg, 52 — at a dose of 0,40 mg/kg, while 50 patients received eptifibatide (Integrilin). We conducted clinical and laboratory studies, electrocardiography (ECG), coronary angiography.
Results. According to the criteria "Frequency and severity of hemorrhagic events, including hemorrhagic stroke", "Frequency, severity of other adverse events", there were no differences in safety between Angipure at doses of 0,40 and 0,72 mg/kg and eptifibatide. Complaints, clinical symptoms, vital signs, complete blood count, biochemical and coagulation tests, ECG in patients of different groups were similar and had unidirectional dynamics. The use of Angipure or eptifibatide was considered effective if no adverse outcomes (death, recurrent acute ischemic event, need for urgent revascularization) were observed within 30 days. There were no lethal outcomes. One repeated acute ischemic event was registered in each group. In groups of patients receiving Angipure 0,40 mg/kg and eptifibatide, urgent revascularization was required once each.
Conclusion. Angipure and eptifibatide have similar safety and efficacy.
About the Authors
S. V. LukyanovRussian Federation
Sergey Victorovich Lukyanov - Deputy General Director for Medical and Pharmaceutical Developments.
Moscow
Yu. F. Glukhov
Russian Federation
Yuriy Fedorovich Glukhov - General Director.
Moscow
E. V. T.
Russian Federation
Eugenia Valerievna Tavlueva - Head of the Regional Vascular Center.
Moscow
B. M. Tankhilevich
Russian Federation
Boris Marlenovich Tankhilevich - Anesthesiologist-resuscitator of the Center of Anesthesiology and Resuscitation.
Moscow
D. A. Zateyshchikov
Russian Federation
Dmitry Alexandrovich Zateyshchikov - Head of the Primary Vascular Department.
Moscow
T. V. Khlevchuk
Russian Federation
Tatyana Vasilievna Khlevchuk - Cardiologist.
Moscow
I. B. Bondareva
Russian Federation
Irina Borisovna Bondareva - Professor of the Department of General and Clinical Pharmacology.
Moscow
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Supplementary files
What is already known about the subject?
- An original glycoprotein IIb/IIIa receptor inhibitor Angipure has passed preclinical studies and a Phase I clinical trial. The safety and good tolerability of the drug, antiplatelet effect were demonstrated, and the pharmacokinetics were studied.
What might this study add?
- A multicenter randomized clinical trial of dosing regimen, efficacy and safety of Angipure compared with eptifibatide in patients with ST-segment elevation acute coronary syndrome during high-risk coronary angioplasty with stenting (Phase II) made it possible to preliminary conclude that Angipure is similar to eptifibatide in terms of safety and efficacy.
Review
For citations:
Lukyanov S.V., Glukhov Yu.F., T. E.V., Tankhilevich B.M., Zateyshchikov D.A., Khlevchuk T.V., Bondareva I.B. Results of a pilot clinical trial of the safety and efficacy of an original glycoprotein IIb/IIIa receptor inhibitor in acute coronary syndrome. Cardiovascular Therapy and Prevention. 2023;22(7):3573. (In Russ.) https://doi.org/10.15829/1728-8800-2023-3573. EDN: LPEYHH
ISSN 2619-0125 (Online)