Key result
Clotinab achieves noninferiority to ReoPro with a 0% 30-day major cardiovascular events rate during high-risk PCI.
Why the study?
Does the abciximab biosimilar (Clotinab) prevent major adverse cardiac events in high-risk patients with acute coronary syndrome undergoing percutaneous coronary intervention?
RCT (n=124)
Open-label
Block randomization
Yes
Does the abciximab biosimilar (Clotinab) prevent major adverse cardiac events in high-risk patients with acute coronary syndrome undergoing percutaneous coronary intervention?
Answers are grounded in this paper and cite their sources.
The abciximab biosimilar Clotinab is safe and effective in preventing ischemic complications in high-risk patients undergoing PCI, with a 30-day MACE rate of less than 5%.
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 Clotinab 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: Clotinab is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
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Moon et al. (2008) conducted an RCT in Acute Coronary Syndrome (ACS) (n=124). Clotinab (Platelet Glycoprotein IIb/IIIa Receptor Blocker) vs. ReoPro (abciximab) was evaluated on Onset of major adverse cardiac event (MACE) within 30 days (95% CI 0.00-4.74). Clotinab effectively prevented major adverse cardiac events within 30 days in high-risk patients undergoing percutaneous coronary intervention, demonstrating a 0% event rate that met the noninferiority margin.
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