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

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참고문헌 (29)

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Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. The PURSUIT Trial Investigators / 1998 / Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy / N Engl J Med 339:436~443 google schola International, randomized, controlled trial of lamifiban (a platelet glycoprotein IIb/IIIa inhibitor), heparin, or both in unstable angina. The PARAGON Investigators / 1998 / Platelet IIb/IIIa Antagonism for the Reduction of Acute coronary syndrome events in a Global Organization Network / Circulation 97:2386~2395 google schola Braunwald E / 2002 / ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina) / J Am Coll Cardiol 40:1366~1374 google schola Randomised placebo-controlled trial of effect of eptifibatide on complications of percutaneous coronary intervention: IMPACT-II / 1997 / Integrilin to Minimise Platelet Aggregation and Coronary Thrombosis-II / Lancet 349:1422~1428 google schola Effects of platelet glycoprotein IIb/IIIa blockade with tirofiban on adverse cardiac events in patients with unstable angina or acute myocardial infarction undergoing coronary angioplasty / 1997 / The RESTORE Investigators. Randomized Efficacy Study of Tirofiban for Outcomes and REstenosis / Circulation 96:1445~1453 google schola

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