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 language | English |
|---|---|
| Pages (from-to) | 389-399 |
| Number of pages | 11 |
| Journal | Yonsei medical journal |
| Volume | 49 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2008 Jun 1 |
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All Science Journal Classification (ASJC) codes
- Medicine(all)
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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 journal › Article
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.
UR - http://www.scopus.com/inward/record.url?scp=48649110831&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=48649110831&partnerID=8YFLogxK
U2 - 10.3349/ymj.2008.49.3.389
DO - 10.3349/ymj.2008.49.3.389
M3 - Article
C2 - 18581587
AN - SCOPUS:48649110831
VL - 49
SP - 389
EP - 399
JO - Yonsei Medical Journal
JF - Yonsei Medical Journal
SN - 0513-5796
IS - 3
ER -