A Multicenter, Randomized, Open-Label, Therapeutic, and Exploratory Trial to Evaluate the Tolerability and Efficacy of Platelet Glycoprotein IIb/IIIa Receptor Blocker (Clotinab(TM)) in High-Risk Patients with Percutaneous Coronary Intervention.
10.3349/ymj.2008.49.3.389
- Author:
Jae Youn MOON
1
;
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
Author Information
1. The Heart Center of Chonnam National University Hospital, Gwangju, Korea. Jangys1212@yuhs.ac
- Publication Type:Original Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Clotinab(TM);
ReoPro(R);
acute coronary syndrome;
angioplasty;
platelet
- MeSH:
Acute Coronary Syndrome/surgery;
Adult;
Aged;
Aged, 80 and over;
*Angioplasty, Transluminal, Percutaneous Coronary;
Antibodies, Monoclonal/adverse effects/*therapeutic use;
Drugs, Investigational/adverse effects/therapeutic use;
Female;
Humans;
Immunoglobulin Fab Fragments/adverse effects/*therapeutic use;
Male;
Middle Aged;
Myocardial Ischemia/prevention & control;
Platelet Aggregation Inhibitors/adverse effects/*therapeutic use;
Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors;
Prospective Studies;
Risk Factors;
Treatment Outcome
- From:Yonsei Medical Journal
2008;49(3):389-399
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: This study was designed as a multicenter, randomized, open-label study to evaluate the efficacy and tolerability of Clotinab(TM). 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. Clotinab(TM) 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 Clotinab(TM) 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 Clotinab(TM) was estimated to be less than 5%. There was no clinically significant result in tolerability variables. CONCLUSION: Clotinab(TM) is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
