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.
OBJECTIVE
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).


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.


CONCLUSIONS
Clotinab is an effective and safe medicine in preventing ischemic cardiac complications for high-risk patients who will receive PCI.
Moon
Jae-Youn
JY
The Heart Center of Chonnam National University Hospital, Gwangju, Korea.
Kim
Weon
W
Kim
Ju Han
JH
Ahn
Youngkeun
Y
Jeong
Myung Ho
MH
Kim
Young-Hak
YH
Hong
Myeong-Ki
MK
Park
Seong-Wook
SW
Park
Seung-Jung
SJ
Park
Sungha
S
Ko
Young-Guk
YG
Choi
Donghoon
D
Jang
Yangsoo
Y
D000077284:Abciximab; D054058:Acute Coronary Syndrome / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D015507:Drugs, Investigational / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D015507:Drugs, Investigational; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077284:Abciximab