UMIN-CTR Clinical Trial

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

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Basic information

Public title

PEARL Study(PITAVASTATIN HEART FAILURE Study)

Acronym

PEARL Study(PITAVASTATIN HEART FAILURE Study)

Scientific Title

PEARL Study(PITAVASTATIN HEART FAILURE Study)

Scientific Title:Acronym

PEARL Study(PITAVASTATIN HEART FAILURE Study)

Region

Japan


Condition

Condition

Chronic heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of Pitavastatin for chronic heart failure with mild hypercholesteremia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cardiac death or hospitalization due to worsening CHF.

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pitavastatin group

Interventions/Control_2

Control group

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

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).

Key exclusion criteria

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.

Target sample size

470


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Issei Komuro

Organization

Osaka University Graduate School of Medicine

Division name

Department of Cardiovascular Medicine

Zip code


Address

2-2, Yamada-oka, Suita, Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Takano

Organization

Chiba University Graduate School of Medicine

Division name

Department of Cardiovascular Science and Medicine

Zip code


Address


TEL

043-226-2701

Homepage URL

http://pearl-study.com

Email

pearl-admin@umin.ac.jp


Sponsor or person

Institute

Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Saga University Faculty of Medicine Department of Cardiovascular & Renal Medicine and other institutes

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2006 Year 06 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2006 Year 06 Month 09 Day

Date of IRB


Anticipated trial start date

2006 Year 06 Month 01 Day

Last follow-up date

2011 Year 03 Month 31 Day

Date of closure to data entry

2011 Year 05 Month 01 Day

Date trial data considered complete

2011 Year 07 Month 01 Day

Date analysis concluded

2011 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2006 Year 06 Month 09 Day

Last modified on

2012 Year 07 Month 17 Day



Link to view the page

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