Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in Patients With Acute ST-segment Elevation Myocardial Infarction; ICAT Trial

The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to potential increase of bleeding. Compared bolus injection followed by continuous infusion of Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding complication while maintaining decrease ischemic events. It was also reported that direct intracoronary injection of abciximab might be superior to intravenous injection regarding myocardial perfusion.
Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of acute ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that combination of intracoronary abciximab bolus injection and aspiration thrombectomy might enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial infarction. We will determine whether combination of intracoronary abciximab injection and aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion through index of microcirculatory resistance and cardiac magnetic resonance imaging.

Start Date01 Dec 2010

Sponsor / Collaborator

Yonsei University

NCT00841438

/ CompletedPhase 4IIT

Efficacy of Clotinab in Acute Myocardial Infarction Trial- ST Elevation Myocardial Infarction

The ADMIRAL (Platelet glycoprotein IIb/IIIa inhibition with coronary stenting for acute myocardial infarction) study demonstrated that early administration of abciximab in patients with ST elevation acute myocardial infarction prior to PCI improves clinical outcomes but no specifically designed randomized study has addressed the issue of early upstream use of GP IIb/IIIa inhibitors in ST elevation acute myocardial infarction who are undergoing PCI, especially in the era of routine pretreatment with 600 mg of clopidogrel. Therefore, the objective of the randomized ECLAT-STEMI study was to assess the hypothesis that the early upstream use of Clotinab is a useful therapy in patients with ST elevation MI undergoing PCI compared to "provisional use", even after pretreatment with a 600-mg loading dose of clopidogrel.

Start Date01 Jul 2007

Sponsor / Collaborator

Yonsei University

[+1]

100 Clinical Results associated with Abciximab biosimilar(ISU Abxis Co., Ltd.)

100 Translational Medicine associated with Abciximab biosimilar(ISU Abxis Co., Ltd.)

100 Patents (Medical) associated with Abciximab biosimilar(ISU Abxis Co., Ltd.)

Literatures (Medical) associated with Abciximab biosimilar(ISU Abxis Co., Ltd.)

01 Jan 2012·Circulation journal : official journal of the Japanese Circulation SocietyQ3 · MEDICINE

Efficacy of Clotinab in Acute Myocardial Infarction Trial-ST Elevation Myocardial Infarction (ECLAT-STEMI)

Q3 · MEDICINE

Article

Author: Kim, Byung Ok ; Jeong, Myung-Ho ; Choi, Donghoon ; Gwon, Hyeon-Cheol ; Park, Sang-Min ; Park, Seong-Wook ; Kim, Jung-Sun ; Yoon, Junghan ; Hong, Myeong-Ki ; Kim, Chong Jin ; Hong, Bum Kee ; Ko, Young-Guk ; Seong, In Whan ; Jang, Yangsoo ; for the ECLAT-STEMI Trial investigators ; Tahk, Seung-Jae ; Kim, Byeong-Keuk

BACKGROUND:

This study investigated the efficacy and the safety of the upstream glycoprotein (Gp) IIb/IIIa inhibitor (clotinab; ISU ABXIS, Seoul, Republic of Korea) under 600-mg clopidogrel pretreatment compared with provisional use in ST-elevation myocardial infarction (STEMI).

METHODS AND RESULTS:

A total of 786 STEMI patients were randomized to upstream use in the emergency room (ER) (n = 392) or provisional use during percutaneous coronary intervention (PCI) (n = 394). All patients were prescribed 600-mg clopidogrel in the ER. The primary endpoint was the 30-day incidence of composite events including death, nonfatal myocardial infarction, target vessel revascularization, and stroke. There was no significant difference in the events that occurred in 40 patients (10.2%) in the upstream arm and 55 patients (14.0%) in the provisional arm during the 30 days (odds ratio 0.70, 95% confidence interval 0.45-1.08). Major bleeding was higher in the upstream arm (1.5% vs. 0%, P = 0.02). However, there was a significant reduction in 30-day composite events in the upstream arm in the high-risk population (Killip class ≥II or GRACE score >140).

CONCLUSIONS:

The upstream use of clotinab under a 600-mg clopidogrel loading may not significantly reduce cardiac events following primary PCI but may improve the clinical outcome in high-risk patients.

01 Apr 2010·Journal of cardiology cases

Sequential development of cardiac tamponade and subacute stent thrombosis after primary percutaneous coronary intervention for acute ST-segment elevation myocardial infarction: A case report

Author: Kang, Jung Chaee ; Sim, Doo Sun ; Ahn, Young Keun ; Park, Keun Ho ; Jeong, Myung Ho ; Kim, Sung Soo ; Hong, Young Joon ; Kim, Ju Han

A 42-year-old male suffered from ST elevation myocardial infarction and underwent successful percutaneous coronary intervention (PCI) of the left anterior descending coronary artery (LAD) with drug-eluting stent using intravenous glycoprotein IIB/IIIa inhibitor (Clotinab^®, Isu Abxis). Five hours after PCI, the patient developed cold sweating and went into a stupor. Urgent 2D-echocardiography showed a large amount of pericardial effusion and akinesia in the LAD territory. A repeat emergent angiography (CAG) was done to ascertain whether acute stent thrombosis or coronary perforation had occurred after PCI. The CAG showed, however, no leakage of dye or thrombus in any coronary arteries with a patent stent in the middle LAD. Approximately 200 cm³ of bloody pericardial effusion was drained, and his blood pressure returned to normal immediately after pericardiocentesis. Seven days later, he again developed sudden hypotension, bradycardia, and loss of consciousness. The ECG showed ST elevation in V1-V6 and 2D-echocardiography showed scanty pericardial effusion. Emergent CAG showed total occlusion of the LAD due to subacute stent thrombosis. He was successfully treated with balloon angioplasty and was discharged with dual anti-platelet therapy. A follow-up CAG after 9 months showed good flow without residual stenosis across the stented segment.

01 Jan 2008·Yonsei medical journalQ4 · MEDICINE

A Multicenter, Randomized, Open-Label, Therapeutic, and Exploratory Trial to Evaluate the Tolerability and Efficacy of Platelet Glycoprotein IIb/IIIa Receptor Blocker (Clotinab™) in High-Risk Patients with Percutaneous Coronary Intervention

Q4 · MEDICINE

ArticleOA

Author: Ko, Young-Guk ; Choi, Donghoon ; Kim, Ju Han ; Kim, Young-Hak ; Moon, Jae-Youn ; Park, Sungha ; Hong, Myeong-Ki ; Ahn, Youngkeun ; Jeong, Myung Ho ; Park, Seong-Wook ; Kim, Weon ; Jang, Yangsoo ; Park, Seung-Jung

PURPOSE:

This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab. We expected to obtain same results as with ReoPro in improving ischemic cardiac complications in high-risk patients who were about to undergo percutaneous coronary intervention (PCI).

PATIENTS AND METHODS:

Patients of 19-80 years of age with acute coronary syndrome (ACS) who were about to undergo PCI were enrolled. After screening and confirmation of eligibility, patients were randomly assigned to different groups. Clotinab was given to 84 patients (58.7+/-10.6 years, M:F=68:16)and ReoPro(59.0+/-10.5 years, M:F=30:10) was given to 40 patients before PCI. The primary efficacy endpoint was the onset of major adverse cardiac event (MACE) within 30 days from day 1. The tolerability endpoints were assessed based on bleeding, thrombocytopenia, change in Hb/Hct, human antichimetric antibody development, and adverse events.

RESULTS:

The number of Clotinab patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact CI was [0.00-4.74%]. A major bleeding event developed in 3 patients in the ReoPro group. The probability of MACE onset in Clotinab was estimated to be less than 5%. There was no clinically significant result in tolerability variables.

CONCLUSION:

Clotinab is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.

News (Medical) associated with Abciximab biosimilar(ISU Abxis Co., Ltd.)

14 Apr 2021

·www.globenewswire.com

New York, April 14, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Biosimilar Monoclonal Antibodies Forecast 2020-2030" - • Along with revenue prediction for the overall world market for biosimilar monoclonal antibodies, our investigation shows forecasts to 2027 for the market segmented by compound: • Infliximab • Rituximab • Abciximab • Trastuzumab • Adalimumab • Bevacizumab • This report also shows revenue to 2027 for individual biosimilar mAb products in the market: • Remsima/Inflectra • Infimab • Reditux • BI695500 • CT-P10 • BI695501 • FKB327 • FKB238 • Mabtas • AcellBia • Maball • Clotinab • Abcixirel • BCD-022 • BCD-021 • Herzuma • CANMAB/Hertraz • Our analyses show individual revenue forecasts to 2027 for these regional and national markets: • The US Biosimilar mAb Market • Japanese Biosimilar mAb Market • EU5 Biosimilar mAb Markets • BRIC and South Korea Biosimilar mAb Markets • Rest of the World Biosimilar mAb Market • This report profiles 10 leading companies either with biosimilar mAbs already on the market or in the pipeline • Our study discusses strengths, weaknesses, opportunities and threats affecting the biosimilar monoclonal antibodies market Read the full report: About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. __________________________

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100 Deals associated with Abciximab biosimilar(ISU Abxis Co., Ltd.)

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Indication	Country/Location	Organization	Date
Angina Pectoris	South Korea	ISU Abxis Co., Ltd.	28 Dec 2006
Myocardial Infarction	South Korea	ISU Abxis Co., Ltd.	28 Dec 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00841438 (ECLAT-STEMI, Pubmed \| Circ J)	Phase 4	ST Elevation Myocardial Infarction \| Acute myocardial infarction	786	Upstream use in the emergency room	ozgmqbonrx(zttfbzszir) = qvcyjegrov vnfranmmqo (mnaqkhyiak )	-	01 Jan 2012

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