Safety and Exploratory Efficacy of the Novel Thrombin Receptor (PAR-1) Antagonist SCH530348 for Non-ST-Segment Elevation Acute Coronary Syndrome
| Autor: | Tetsu Yamaguchi, Shinya Goto, Yasuo Ikeda, Jensen Peder K, Hiroya Yamaguchi, Kenichi Kato |
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| Rok vydání: | 2010 |
| Předmět: |
Blood Platelets
Male Acute coronary syndrome Ticlopidine Pyridines Loading dose Cohort Studies Placebos Lactones Double-Blind Method Japan Internal Medicine medicine Humans Receptor PAR-1 cardiovascular diseases Acute Coronary Syndrome Aged Aspirin Heparin business.industry Biochemistry (medical) Middle Aged Clopidogrel medicine.disease surgical procedures operative Anesthesia Conventional PCI Female Cardiology and Cardiovascular Medicine business Mace TIMI medicine.drug |
| Zdroj: | Journal of Atherosclerosis and Thrombosis. 17:156-164 |
| ISSN: | 1880-3873 1340-3478 |
| DOI: | 10.5551/jat.3038 |
| Popis: | Aim: A previous phase 2 study of patients undergoing non-urgent PCI treated with SCH530348 plus aspirin and clopidogrel tended to reduce MACE without increased bleeding. This study evaluated the safety of SCH530348 in Japanese patients with NSTE ACS.Methods: Subjects (117), in whom PCI was planned, received standard-of-care (aspirin, ticlopidine, and heparin) and were randomized 4:1 to receive either SCH530348 (20 or 40 mg loading dose followed by 1 mg/d or 2.5 mg/d for 60 days) or placebo. The key safety endpoint was TIMI major and minor bleeding in the PCI cohort (n=92). The key exploratory efficacy endpoint was MACE and death within 60 days. Addition of SCH530348 to standard-of-care did not significantly increase the rate of TIMI major and minor bleeding (or non-TIMI bleeding) in the primary cohort.Results: Incidence (non-MACE) and discontinuation of AEs were similar across groups. PCI subjects treated with SCH530348 plus standard-of-care experienced a significant reduction in periprocedural MI compared with standard-of-care alone (16.9% vs 42.9%, respectively; p=0.013). There were no deaths or any other MACE.Conclusion: SCH530348 added to standard-of-care did not result in excess bleeding in Japanese subjects with NSTE ACS but significantly reduced the incidence of periprocedural MI in subjects undergoing urgent PCI. |
| Databáze: | OpenAIRE |
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