UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015122 |
|---|---|
| Receipt number | R000017593 |
| Scientific Title | The effect of changing thienopyridine drugs on platelet aggregation for patients with acute and elective stent placement in coronary artery |
| Date of disclosure of the study information | 2014/09/19 |
| Last modified on | 2016/03/11 16:43:10 |
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Basic information
Public title
The effect of changing thienopyridine drugs on platelet aggregation for patients with acute and elective stent placement in coronary artery
Acronym
Comparison of novel antiplatelet agent prasugrel versus clopidogrel switched from prasugrel with aspirin treatment in Japanese patients undergoing PCI (CONTINUE VERSUS SWITCH-Kyushu)
Scientific Title
The effect of changing thienopyridine drugs on platelet aggregation for patients with acute and elective stent placement in coronary artery
Scientific Title:Acronym
Comparison of novel antiplatelet agent prasugrel versus clopidogrel switched from prasugrel with aspirin treatment in Japanese patients undergoing PCI (CONTINUE VERSUS SWITCH-Kyushu)
Region
| Japan |
Condition
Condition
Ischemic heart diseases with PCI
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Clarification on the change of platelet aggregation inhibiting effect between prasugrel only and clopidogrel switched from prasugrel during treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PRU value at 6 weeks after the initial dose
Key secondary outcomes
PRU value by genetic polymorphism of the CYP2C19 gene
Frequency of hemorrhagic adverse events during the dosing period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prasugrel
Interventions/Control_2
clopidogrel
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 at least 20 years old
(2) Patients who give written consent
(3) Patients who are diagnosed as ACS and planned to undergo PCI or patients who are diagnosed as coronary heart disease and planned to undergo elective stent treatment in coronary artery
Key exclusion criteria
(1) Patients with tendency or factor of bleeding
(2) Patients with severe hepatic dysfunction
(3) Patients with severe renal dysfunction
(4) Patients under antihypertensive therapy or with poor control of blood pressure
(5) Patients with a history of cerebral infarction or transient cerebral ischemia
(6) Patients with hypersensitivity to thienopyridine
(7) Patients receiving thienopyridine within 30 days of the initial dose
(8) Patients who have difficulties in participation in this study by the investigator's judgment
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Ueno |
Organization
Kurume University Hospital
Division name
Center of Cardio-vascular Disease
Zip code
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-35-3311
takueno@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Ueno |
Organization
Kurume University Hospital
Division name
Center of Cardio-vascular Disease
Zip code
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-35-3311
Homepage URL
takueno@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Hospital
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
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
| 2014 | Year | 09 | 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
| 2014 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 19 | 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
| 2014 | Year | 09 | Month | 11 | Day |
Last modified on
| 2016 | 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=R000017593
