| Budget Amount *help |
¥3,600,000 (Direct Cost: ¥3,600,000)
Fiscal Year 2006: ¥1,700,000 (Direct Cost: ¥1,700,000)
Fiscal Year 2005: ¥1,900,000 (Direct Cost: ¥1,900,000)
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| Research Abstract |
We approached several corporations asking for placebo offering to conduct a double blind trial, however, negotiation had not been successful. Finally, one corporation agreed, we requested the registration and randomization of cases at CRes Kyushu. Objects were changed to the patients who undergoing percutatneous coronary intervention (PCI), not restricted to ones with acute coronary syndrome. Primary endpoint was also changed from cardiovascular events to the rise in the myocardial enzyme leakage. Twelve cases including 3 with ACS were enrolled. The test medicine treatment of 1 week (rosuvastatin 5mg or placebo) decreased LDL cholesterol from 124±21 mg/dl to 101±26 and furthermore decreased to 93±25, 2 weeks later. Almost all cases showed decreases 2 weeks later, suggesting an influence of hospital diet therapy. With time-dependent blood-collecting, CK-MB before PCI:6.8±2.6u/lincreased to 11.8±7.8 at 12-24 hours after PCI but there was no case reaching the EP which is greater than twic
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e the normal upper limit. As for troponin T, it was 0.001±0.003ng/ml before PCI and after PCI: 0.117±0.176,4 examples exceeded the normal upper limit as the EP. As for CRP it was 0.14±0.11mg/dl before the test medicine injestion. It became 0.27±0.25 1 week later before PCI and rose to 1.38±1.21after PCI. Concerning PM-1 of blood platelet activation index, it was 31.6±26.2ng/ml before the drug injestion and decreased somewhat to 16.5±11.0, 1 week later before PCI. After PCI it re-rose to 36.2±18.1. No index showed clear correlation with LDL decrease magnitude. One example showed no reflow and showed myocardial enzyme leakage. Restenosis was recognized in 2 cases out of 9 which underwent follow-up catheterization half year later. In recent 1-2 years, the statins are prescribed widely even in the ischemic heart disease patients who do not have hyperlipidemia, which exludes large portion of patients from this study. Therefore, we have not yet reached to the number of target cases to open blinding. The trial execution in preplanned way became difficult because clinical practice changed while unexpected time is spent to assure placebo. If the environmental improvement to enforce the clinical trials other than “Chiken," the ones for market approval, with double blind fashion is not done, it is and will be difficult to get the result with high evidence level in Japan. Less
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