UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prevention of Coronary Artery Spasm by Strong Statin, Open Label, Randomized Controlled Trial (PRINCESS trial)
Title of the study (Brief title)	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	Kohei Wakabayashi
Organization	Showa University Fujigaoka Hospital
Division name	Division of Cardiology
Address	1-30 Fujigaoka, Aoba-ku, Yokohama City, Kanagawa, Japan.
TEL	045-971-1151
Email	kwaka@live.jp

Public contact
Name of contact person	Kohei Wakabayashi
Organization	Showa University Fujigaoka Hospital
Division name	Division of Cardiology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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