Rationale and Design of the PROSPECTIVE Trial: Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease
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- Yamashita Shizuya
- Department of Community Medicine, Osaka University Graduate School of Medicine Rinku General Medical Center
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- Masuda Daisaku
- Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
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- Ohama Tohru
- Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine Department of Dental Anesthesiology, Osaka University Graduate School of Dentistry
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- Arai Hidenori
- The National Center for Geriatrics and Gerontology
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- Bujo Hideaki
- Department of Clinical Laboratory and Experimental Research Medicine, Toho University, Sakura Medical Center
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- Kagimura Tatsuo
- Foundation for Biomedical Research and Innovation
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- Kita Toru
- Kobe City Medical Center General Hospital
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- Matsuzaki Masunori
- Yamaguchi University Graduate School of Medicine
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- Saito Yasushi
- Chiba University Graduate School of Medicine
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- Fukushima Masanori
- Foundation for Biomedical Research and Innovation
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- Matsuzawa Yuji
- Sumitomo Hospital
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Background: Reduction of serum LDL-cholesterol by statins was shown to improve clinical outcomes in patients with coronary heart disease (CHD). Although intensive statin therapy significantly reduced cardiovascular risks, atherosclerotic cardiovascular events have not been completely prevented. Therefore, effective pharmacologic therapy is necessary to improve “residual risks” in combination with statins. Probucol has a potent antioxidative effect, inhibits the oxidation of LDL, and reduces xanthomas. Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease (PROSPECTIVE) is a multicenter, randomized, prospective study designed to test the hypothesis that the addition of probucol to other lipid-lowering drugs will prevent cerebro- and cardiovascular events in patients with prior coronary events and high LDL cholesterol levels.<br>Study Design: The study will recruit approximately 860 patients with a prior CHD and dyslipidemia with LDL-C level ≥140 mg/dl without any medication and those treated with any lipid-lowering drugs with LDL-C level ≥100 mg/dl. Lipid-lowering agents are continuously administered during the study period in control group, and probucol (500 mg/day, 250 mg twice daily) is added to lipid-lowering therapy in the test group. The efficacy and safety of probucol with regard to the prevention of cerebro- and cardiovascular events and the intima-media thickness of carotid arteries as a surrogate marker will be evaluated.<br>Summary: PROSPECTIVE will determine whether the addition of probucol to other lipid-lowering drugs improves cerebro- and cardiovascular outcomes in patients with prior coronary heart disease. Furthermore, the safety of a long-term treatment with probucol will be clarified.
収録刊行物
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- Journal of Atherosclerosis and Thrombosis
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Journal of Atherosclerosis and Thrombosis 23 (6), 746-756, 2016
一般社団法人 日本動脈硬化学会