UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006002 |
|---|---|
| Receipt number | R000007101 |
| Scientific Title | Effectiveness of intracoronary bolus abciximab application for patients who suffer from No-Reflow or Slow flow phenomenon during PCI |
| Date of disclosure of the study information | 2011/07/19 |
| Last modified on | 2018/09/05 11:27:03 |
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Basic information
Public title
Effectiveness of intracoronary bolus abciximab application for patients who suffer from No-Reflow or Slow flow phenomenon during PCI
Acronym
Effectiveness of intracoronary bolus abciximab application for No-Reflow or Slow flow phenomenon during PCI
Scientific Title
Effectiveness of intracoronary bolus abciximab application for patients who suffer from No-Reflow or Slow flow phenomenon during PCI
Scientific Title:Acronym
Effectiveness of intracoronary bolus abciximab application for No-Reflow or Slow flow phenomenon during PCI
Region
| Japan |
Condition
Condition
Patients suffer from No-Reflow or Slow flow phenomenon during PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of intracoronary bolus abciximab application for patients who suffer from No-Reflow or Slow flow phenomenon during PCI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of attrition of ST elevation ratio :Comparison between at 30 minutes after PCI and at the time of maximum ST elevation
Key secondary outcomes
1. Rate of ST re-elevation after intracoronary bolus application of drug(s)
2. TIMI flow after PCI
3. Myocardial blush grade after PCI
4. Maximum value of CPK/CPK-MB after PCI
5. MACCE at 30 days / 1 year after PCI
6. Existence or nonexistence of serious hemorrhagic complication
7. Angiographical phenomenon at follow-up CAG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Abciximab (+)
Interventions/Control_2
Abciximab (-)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with coronary artery disease
2. Patients who take aspirin and thienopyridine
3. Informed consent was obtained from patients
Key exclusion criteria
1.with hemorrhagic diathesis and/or hypercoagulability
2.under emergent PCI
3.received thrombolytic therapy before PCI
4.more than twice the value of standard CPK and CPK-MB
5.be pregnant or nursing
6.with unprotected LMT disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Mitsudo |
Organization
Kurashiki Central Hospital
Division name
Department of Cardiology
Zip code
Address
Kurashiki city miwa 1-1-1, Okayama, Japan
TEL
086-422-0210
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daiji Hasegawa |
Organization
Kurashiki Central Hospital
Division name
Department of Cardiology
Zip code
Address
Kurashiki city miwa 1-1-1, Okayama, Japan
TEL
086-422-0210
Homepage URL
dh10969@kchnet.or.jp
Sponsor or person
Institute
Department of Cardiology, Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiology, Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
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
倉敷中央病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 19 | 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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 19 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007101
