Koichiro Fujisue1, Takuhiro Shirakawa2, Shinichi Nakamura3, Nobuyasu Yamamoto4, Shuichi Oshima5, Toshiyuki Matsumura6, Ryusuke Tsunoda7, Nobutaka Hirai8, Shinji Tayama9, Natsuki Nakamura10, Toyoki Hirose11, Hideki Maruyama11, Kazuteru Fujimoto12, Ichiro Kajiwara13, Tomohiro Sakamoto14, Koichi Nakao14, Naritsugu Sakaino15, Seiji Hokimoto1, Yasuhiro Nagayoshi16, Jun Hokamaki17, Hideki Shimomura2, Kenji Sakamoto1, Eiichiro Yamamoto1, Yasuhiro Izumiya1, Koichi Kaikita1, Hisao Ogawa18, Kenichi Tsujita19. 1. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. 2. Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center, Kasuga, Japan. 3. Division of Cardiology, Health Insurance Hitoyoshi General Hospital, Hitoyoshi, Japan. 4. Division of Cardiology, Miyazaki Prefectural Nobeoka Hospital, Nobeoka, Japan. 5. Division of Cardiology, Kumamoto Central Hospital, Kumamoto, Japan. 6. Division of Cardiology, Japan Labor Health and Welfare Organization Kumamoto Rosai Hospital, Yatsushiro, Japan. 7. Division of Cardiology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan. 8. Division of Cardiology, Kumamoto Regional Medical Center, Kumamoto, Japan. 9. Division of Cardiology, Health Insurance Kumamoto General Hospital, Yatsushiro, Japan. 10. Division of Cardiology, Shin-Beppu Hospital, Beppu, Japan. 11. Division of Cardiology, Minamata City General Hospital & Medical Center, Minamata, Japan. 12. Department of Cardiology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan. 13. Division of Cardiology, Arao Municipal Hospital, Arao, Japan. 14. Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan. 15. Division of Cardiology, Amakusa Medical Center, Amakusa, Japan. 16. Division of Cardiology, Aso Medical Center, Aso, Japan. 17. Division of Cardiology, Tamana Central Hospital, Tamana, Japan. 18. National Cerebral and Cardiovascular Center, Suita, Japan. 19. Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan. Electronic address: tsujita@kumamoto-u.ac.jp.
Abstract
BACKGROUND: Acute myocardial infarction (AMI) is mainly characterized by the rupture of lipid-rich vulnerable atherosclerotic plaque. The matrix metalloproteinases (MMPs) have been shown to play a critical role in inflammatory processes underlying plaque rupture. Some reports suggested statins inhibit the increased MMP levels after AMI. However, there are a few comparison studies between the different dosages of the same statin and circulating levels of MMPs. PURPOSE: This study will preliminarily investigate the potential effects of appropriate or low dose of rosuvastatin on circulating MMPs levels in AMI patients. Moreover, we will also obtain plasma from patients while undergoing diagnostic angiography to determine differences in various cardiac sites and peripheral vessels. METHODS: This study is a multicenter, open-label, randomized, parallel-group study to be conducted to compare the appropriate or low dose of rosuvastatin in the effect on serum levels of inflammatory markers in AMI patients. The eligible patients undergoing percutaneous coronary intervention (PCI) will be randomly assigned to receive either appropriate or low-dose rosuvastatin daily using a web-based randomization software within 24h after PCI. The low-dose group will be treated with rosuvastatin 2.5mg once daily with a follow-up. The appropriate-dose group will begin treatment with rosuvastatin 5mg once daily, and the dose of rosuvastatin will be titrated to 10mg within 4 weeks. During administration of the study treatment, subjects will undergo laboratory testing including MMPs and be monitored for the occurrence of adverse events up to 24 weeks. The primary endpoint will be the change rate of MMPs at 24 weeks after administration. CONCLUSIONS: INVITATION will compare the appropriate or low dose of rosuvastatin in the effects on serum levels of inflammatory markers including MMPs in AMI patients. This study will provide significant information on rosuvastatin as an anti-inflammatory agent for AMI.
RCT Entities:
BACKGROUND:Acute myocardial infarction (AMI) is mainly characterized by the rupture of lipid-rich vulnerable atherosclerotic plaque. The matrix metalloproteinases (MMPs) have been shown to play a critical role in inflammatory processes underlying plaque rupture. Some reports suggested statins inhibit the increased MMP levels after AMI. However, there are a few comparison studies between the different dosages of the same statin and circulating levels of MMPs. PURPOSE: This study will preliminarily investigate the potential effects of appropriate or low dose of rosuvastatin on circulating MMPs levels in AMI patients. Moreover, we will also obtain plasma from patients while undergoing diagnostic angiography to determine differences in various cardiac sites and peripheral vessels. METHODS: This study is a multicenter, open-label, randomized, parallel-group study to be conducted to compare the appropriate or low dose of rosuvastatin in the effect on serum levels of inflammatory markers in AMI patients. The eligible patients undergoing percutaneous coronary intervention (PCI) will be randomly assigned to receive either appropriate or low-dose rosuvastatin daily using a web-based randomization software within 24h after PCI. The low-dose group will be treated with rosuvastatin 2.5mg once daily with a follow-up. The appropriate-dose group will begin treatment with rosuvastatin 5mg once daily, and the dose of rosuvastatin will be titrated to 10mg within 4 weeks. During administration of the study treatment, subjects will undergo laboratory testing including MMPs and be monitored for the occurrence of adverse events up to 24 weeks. The primary endpoint will be the change rate of MMPs at 24 weeks after administration. CONCLUSIONS: INVITATION will compare the appropriate or low dose of rosuvastatin in the effects on serum levels of inflammatory markers including MMPs in AMI patients. This study will provide significant information on rosuvastatin as an anti-inflammatory agent for AMI.