UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008321
Receipt number R000009536
Scientific Title Prospective randomized trial for optimizing medical therapy after coronary stenitng
Date of disclosure of the study information 2012/07/03
Last modified on 2017/02/27 17:36:05

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Basic information

Public title

Prospective randomized trial for optimizing medical therapy after coronary stenitng

Acronym

Calcium-Beta

Scientific Title

Prospective randomized trial for optimizing medical therapy after coronary stenitng

Scientific Title:Acronym

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

1st name
Middle name
Last name Shun Kohsaka

Organization

Keio University, School of Medicine

Division name

Division of Cardiology

Zip code


Address

35 Shinanomachi Shinjuku Tokyo Japan 160-8582

TEL

03-3353-1211

Email

sk@keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shun Kohsaka

Organization

Keio University, School of Medicine

Division name

Division of Cardiology

Zip code


Address

35 Shinanomachi Shinjuku Tokyo Japan 160-8582

TEL

03-3353-1211

Homepage URL


Email

sk@keio.jp


Sponsor or person

Institute

Keio University, School of Medicine

Institute

Department

Personal name



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)



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

2012 Year 07 Month 03 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

Main results already published

Date of protocol fixation

2012 Year 05 Month 20 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name