UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective randomized trial for optimizing medical therapy after coronary stenitng
Title of the study (Brief title)	Calcium-Beta
Region	Japan

Condition
Condition	Coronary artery disease (CAD)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The study will test whether calcium channel blockers would provide equal or additional benefit compared to standard beta-blocker therapy in Japanese patients who underwent stenting of single vessel lesion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Presence of Acetylcholine induced coronary vasospasm 9 month after PCI
Key secondary outcomes	All cause death MACEE: acute myocardial infarction, stable or unstable angina, any coronary revascularization procedure, or cerebrovascular accident

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	calcium channel blockers (CCBs)
Interventions/Control_2	Beta blockers
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients with stable/unstable angina or silent ischemia who underwent PCI with everolimus eluting stent. 2.Single vessel disease with deployment of 3 stents or less. 3.Patients must be 20 years of age or more.
Key exclusion criteria	1.Stent restenosis or previous bypass surgery. 2.Previous diagnosis of vasospasmic angina within 1 years and/or on treatment. 3.Previous PCI within 1 years. 4.An event of acute myocardial infarction within 7 days. 5.Left main disease. 6.Left ventricular ejection fraction of less than 35%. 7.Previous Pacemaker Implant or AV block of more than 1st degree. 8.SBP less than 100 or HR less than 60 prior to PCI. 9.Renal failure (Cr more than 2.0mg/dl or on hemodialysis) 10.Liver failure (eg. cirrhosis) 11.Reversible obstructive lung disease 12.Diagnosis of malignancy within 5 years 13.Pregnancy
Target sample size	100

Research contact person
Name of lead principal investigator	Shun Kohsaka
Organization	Keio University, School of Medicine
Division name	Division of Cardiology
Address	35 Shinanomachi Shinjuku Tokyo Japan 160-8582
TEL	03-3353-1211
Email	sk@keio.jp

Public contact
Name of contact person	Shun Kohsaka
Organization	Keio University, School of Medicine
Division name	Division of Cardiology
Address	35 Shinanomachi Shinjuku Tokyo Japan 160-8582
TEL	03-3353-1211
Homepage URL
Email	sk@keio.jp

Sponsor
Institute	Keio University, School of Medicine
Institute
Department

Funding Source
Organization	Pfizer Japan Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

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

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 03 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 05 Month 20 Day
Anticipated trial start date	2012 Year 06 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	2012 Year 07 Month 02 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009536