Unique ID issued by UMIN | UMIN000011026 |
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Receipt number | R000012887 |
Scientific Title | Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial) |
Date of disclosure of the study information | 2013/07/01 |
Last modified on | 2017/07/24 22:58:29 |
Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial)
Prevention of Coronary Artery Spasm by Strong Statin(PRINCESS trial)
Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial)
Prevention of Coronary Artery Spasm by Strong Statin(PRINCESS trial)
Japan |
Coronary Artery Disease
Cardiology |
Others
NO
To evaluate the effect of Rosuvastatin for coronary spasm
Safety,Efficacy
Comparison of incidence of provoked coronary artery spasm at 6-month follow-up between Rosuvastatin group and control group
Comparison of incidence of provoked coronary artery spasm at 6-month follow-up between Rosuvastatin high dose and low dose group and control group
Relationship between lipid profiles and provoked coronary artery spasm rate
Relationship between endothelial function and provoked coronary artery spasm rate
Adverse events, side effect event
Interventional
Parallel
Randomized
Open -but assessor(s) are blinded
Active
3
Treatment
Medicine |
Treatment with rosuvastatin 20mg once daily
(Treatment begins from 5mg/day)
Treatment with rosuvastatin 2.5mg once daily
Dietetic treatment and therapeutic exercise
20 | years-old | <= |
Not applicable |
Male and Female
Patients with provoked coronary artery spasm.
Boundary high LDL cholesterolemia.
(100<=LDL-C<=139mg/dL)
Patient who agreed with document.
Patients who take statin already.
Patients with familial hypercholesterolemia or secondary hyperlipidemia.
Serum TG is 400mg/dL or more.
Patients who have hypersensitivity for statin.
Patients who have active liver disease.
Patients who have renal dysfunction.
Serum CK is 500IU/L or more.
Patients who take cyclosporine.
Pregnancy or possibility of pregnancy.
Patients who have hypothyroidism, inherited stripe disease (muscular dystrophy etc.) or the family medical histories and patients who have previous history of medicinal muscle disorder.
Patient of drug abuse or alcoholism.
Additionally, patients who do not receive physician's approval.
80
1st name | |
Middle name | |
Last name | Kohei Wakabayashi |
Showa University Fujigaoka Hospital
Division of Cardiology
1-30 Fujigaoka, Aoba-ku, Yokohama City, Kanagawa, Japan.
045-971-1151
kwaka@live.jp
1st name | |
Middle name | |
Last name | Kohei Wakabayashi |
Showa University Fujigaoka Hospital
Division of Cardiology
1-30 Fujigaoka, Aoba-ku, Yokohama City, Kanagawa, Japan.
045-971-1151
kwaka@live.jp
Showa University Fujigaoka Hospital
Showa University Fujigaoka Hospital
Self funding
NO
昭和大学藤が丘病院(神奈川県)
2013 | Year | 07 | Month | 01 | Day |
Unpublished
Terminated
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 07 | Month | 01 | Day |
2013 | Year | 06 | Month | 24 | Day |
2017 | Year | 07 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012887
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