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
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
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
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
