Unique ID issued by UMIN | C000000428 |
---|---|
Receipt number | R000000518 |
Scientific Title | PEARL Study(PITAVASTATIN HEART FAILURE Study) |
Date of disclosure of the study information | 2006/06/09 |
Last modified on | 2012/07/17 19:34:47 |
PEARL Study(PITAVASTATIN HEART FAILURE Study)
PEARL Study(PITAVASTATIN HEART FAILURE Study)
PEARL Study(PITAVASTATIN HEART FAILURE Study)
PEARL Study(PITAVASTATIN HEART FAILURE Study)
Japan |
Chronic heart failure
Cardiology |
Others
NO
To evaluate the efficacy of Pitavastatin for chronic heart failure with mild hypercholesteremia.
Efficacy
Cardiac death or hospitalization due to worsening CHF.
Total mortality
Cardiac death
Hospitalization due to worsening CHF
Acute myocardial infarction or unstable angina pectoris
Cerebral stroke
Undergo percutaneous coronary intervention
Surgical therapy for worsening CHF
Composite of above
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Pitavastatin group
Control group
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) NYHA Classification class 2 or 3.
2) LVEF<=45% in UCG.
3) Patients who are stable for more than two weeks on NYHA Classification.
4) Patients with mild hypercholesteremia
(T-Cho<=250mg/dL or LDL-Cho<=170mg/dL).
1) Patients who had already treated with statin.
2)Patients who will undertake changes of alternative treatment of CHF.
3) Myocardial infarction occurred within three months.
4) CABG or PCI performed within three months, or planning them.
5) Patients with active malignant tumor.
6) Patients with severe renal and hepatic dysfunction.
7) Patients with collagen disease.
8) Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant during the study period.
9) Patients whose consent is not obtained from themselves in written form.
10) Other patients judged as being inappropriate for the subjects of the study by investigators.
470
1st name | |
Middle name | |
Last name | Issei Komuro |
Osaka University Graduate School of Medicine
Department of Cardiovascular Medicine
2-2, Yamada-oka, Suita, Osaka
1st name | |
Middle name | |
Last name | Hiroyuki Takano |
Chiba University Graduate School of Medicine
Department of Cardiovascular Science and Medicine
043-226-2701
http://pearl-study.com
pearl-admin@umin.ac.jp
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
None
Self funding
Saga University Faculty of Medicine Department of Cardiovascular & Renal Medicine and other institutes
NO
2006 | Year | 06 | Month | 09 | Day |
Unpublished
Completed
2006 | Year | 06 | Month | 09 | Day |
2006 | Year | 06 | Month | 01 | Day |
2011 | Year | 03 | Month | 31 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 10 | Month | 01 | Day |
2006 | Year | 06 | Month | 09 | Day |
2012 | Year | 07 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000518
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |