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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011026
Receipt No. 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

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Basic information
Public title Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial)
Acronym Prevention of Coronary Artery Spasm by Strong Statin(PRINCESS trial)
Scientific Title Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial)
Scientific Title:Acronym Prevention of Coronary Artery Spasm by Strong Statin(PRINCESS trial)
Region
Japan

Condition
Condition Coronary Artery Disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of Rosuvastatin for coronary spasm
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of incidence of provoked coronary artery spasm at 6-month follow-up between Rosuvastatin group and control group
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with rosuvastatin 20mg once daily
(Treatment begins from 5mg/day)
Interventions/Control_2 Treatment with rosuvastatin 2.5mg once daily
Interventions/Control_3 Dietetic treatment and therapeutic exercise
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with provoked coronary artery spasm.
Boundary high LDL cholesterolemia.
(100<=LDL-C<=139mg/dL)
Patient who agreed with document.
Key exclusion criteria 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.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kohei Wakabayashi
Organization Showa University Fujigaoka Hospital
Division name Division of Cardiology
Zip code
Address 1-30 Fujigaoka, Aoba-ku, Yokohama City, Kanagawa, Japan.
TEL 045-971-1151
Email kwaka@live.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kohei Wakabayashi
Organization Showa University Fujigaoka Hospital
Division name Division of Cardiology
Zip code
Address 1-30 Fujigaoka, Aoba-ku, Yokohama City, Kanagawa, Japan.
TEL 045-971-1151
Homepage URL
Email kwaka@live.jp

Sponsor
Institute Showa University Fujigaoka Hospital
Institute
Department

Funding Source
Organization Showa University Fujigaoka Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 昭和大学藤が丘病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 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 Terminated
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 24 Day
Last modified on
2017 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012887

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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