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KMID : 0311120080490030389
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Yonsei Medical Journal
2008 Volume.49 No. 3 p.389 ~ p.399
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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 (ClotinabTM) in High-Risk Patients with Percutaneous Coronary Intervention
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Moon Jae-Youn
Hong Myeong-Ki
Kim Young-Hak
Park Seong-Wook
Park Seung-Jung
Jeong Myung-Ho
Ahn Young-Keun
Kim Ju-Han
Choi Dong-Hoon
Kim Weon
Jang Yang-Soo
Park Sung-Ha
Ko Young-Guk
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Abstract
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Purpose: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of ClotinabTM. We expected to obtain same results as with ReoPro(R) 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. ClotinabTM was given to 84 patients (58.7 ± 10.6 years, M:F=68:16)and ReoPro(R) (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 ClotinabTM 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(R) group. The probability of MACE onset in ClotinabTM was estimated to be less than 5%. There was no clinically significant result in tolerability variables.
Conclusion: ClotinabTM is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
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KEYWORD
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ClotinabTM, ReoPro(R), acute coronary syndrome, angioplasty, platelet
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