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

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

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Abstract

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 screehing 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, hange in Hb/Hct, human antichimetric antibody development, and advers events. Results: The nurnber of Clotinab™ patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact Cl 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.

Original languageEnglish
Pages (from-to)389-399
Number of pages11
JournalYonsei medical journal
Volume49
Issue number3
DOIs
Publication statusPublished - 2008 Jun 1

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Integrin beta3
Platelet Glycoprotein GPIIb-IIIa Complex
Percutaneous Coronary Intervention
Therapeutics
abciximab
Hemorrhage
Acute Coronary Syndrome
Thrombocytopenia
Medicine

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{3e40003029e449058113753a8baf484b,
title = "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",
abstract = "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{\circledR} 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 screehing 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{\circledR} (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, hange in Hb/Hct, human antichimetric antibody development, and advers events. Results: The nurnber of Clotinab™ patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0{\%}, and its 95{\%} exact Cl was [0.00-4.74{\%}]. A major bleeding event developed in 3 patients in the ReoPro{\circledR} 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.",
author = "Moon, {Jae Youn} and Weon Kim and Kim, {Ju Han} and Youngkeun Ahn and Jeong, {Myung Ho} and Kim, {Young Hak} and Hong, {Myeong Ki} and Park, {Seong Wook} and Park, {Seung Jung} and Sungha Park and Ko, {Young Guk} and Donghoon Choi and Yangsoo Jang",
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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. / Moon, Jae Youn; Kim, Weon; Kim, Ju Han; Ahn, Youngkeun; Jeong, Myung Ho; Kim, Young Hak; Hong, Myeong Ki; Park, Seong Wook; Park, Seung Jung; Park, Sungha; Ko, Young Guk; Choi, Donghoon; Jang, Yangsoo.

In: Yonsei medical journal, Vol. 49, No. 3, 01.06.2008, p. 389-399.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Moon, Jae Youn

AU - Kim, Weon

AU - Kim, Ju Han

AU - Ahn, Youngkeun

AU - Jeong, Myung Ho

AU - Kim, Young Hak

AU - Hong, Myeong Ki

AU - Park, Seong Wook

AU - Park, Seung Jung

AU - Park, Sungha

AU - Ko, Young Guk

AU - Choi, Donghoon

AU - Jang, Yangsoo

PY - 2008/6/1

Y1 - 2008/6/1

N2 - 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 screehing 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, hange in Hb/Hct, human antichimetric antibody development, and advers events. Results: The nurnber of Clotinab™ patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact Cl 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.

AB - 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 screehing 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, hange in Hb/Hct, human antichimetric antibody development, and advers events. Results: The nurnber of Clotinab™ patients experiencing MACE was 0 out of 76 per protocol (PP) patients. The MACE rate was 0%, and its 95% exact Cl 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.

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