UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003316 |
|---|---|
| Receipt number | R000003945 |
| Scientific Title | Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneus Coronary Intervention Trial(ReACT) |
| Date of disclosure of the study information | 2010/03/15 |
| Last modified on | 2010/03/11 19:32:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneus Coronary Intervention Trial(ReACT)
Acronym
ReACT
Scientific Title
Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneus Coronary Intervention Trial(ReACT)
Scientific Title:Acronym
ReACT
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of routine follow up coronary angiography after percutaneous coronary intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Death/MI/Stroke/Emergency admission for ACS/admission for heart failure at3 years
Key secondary outcomes
Any coronary revascularization at 3 years
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Planning routine follow up coronary angiography in 1650 patients
Interventions/Control_2
No planning routine follow up coronary angiography in 1650 patients
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who recieved PCI and do not have staged PCI.
Key exclusion criteria
The patients who refuse to participate in this study
Target sample size
3300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KIMURA TAKESHI |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
606-8507 54 Kawahara-cho Syogoin Sakyo-ku Kyoto City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SHIOMI HIROKI |
Organization
Kyoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
606-8507 54 Kawahara-cho Syogoin Sakyo-ku Kyoto City
TEL
075-751-4255
Homepage URL
hishiomi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
ReACT Trial
Institute
Department
Personal name
Funding Source
Organization
unfixed
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
nothing
Name of secondary funder(s)
nothing
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
| 2010 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 02 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 03 | Month | 11 | Day |
Last modified on
| 2010 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003945
