UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027089 |
|---|---|
| Receipt number | R000031050 |
| Scientific Title | Comparative study to examine the effects of changing between thienopyridine drugs on platelet aggregation activity for patients who are consistently treated with dual antiplatelet therapy: DAPT (clopidogrel + aspirin) over 52 weeks |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2019/03/18 14:14:15 |
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Basic information
Public title
Comparative study to examine the effects of changing between thienopyridine drugs on platelet aggregation activity for patients who are consistently treated with dual antiplatelet therapy: DAPT (clopidogrel + aspirin) over 52 weeks
Acronym
Comparison of novel antiplatelet agent prasugrel versus clopidogrel in Japanese patients who are consistently treated with DAPT (CONVERT 2)
Scientific Title
Comparative study to examine the effects of changing between thienopyridine drugs on platelet aggregation activity for patients who are consistently treated with dual antiplatelet therapy: DAPT (clopidogrel + aspirin) over 52 weeks
Scientific Title:Acronym
Comparison of novel antiplatelet agent prasugrel versus clopidogrel in Japanese patients who are consistently treated with DAPT (CONVERT 2)
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study enrolls the patients with PRU >=208 who underwent coronary artery stent implantation and who are consistently treated with dual antiplatelet therapy (DAPT: clopidogrel + aspirin) over 52 weeks. They are randomly assigned to either switching clopidogrel to prasugrel or continuing to receive clopidogrel, to evaluate the efficacy of prasugrel in patients who do not respond adequately to clopidogrel by using PRU at Week 12 as the primary endpoint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients who achieve PRU value <208 after 12 weeks.
Key secondary outcomes
1. Epidemiological classification by DAPT score.
2. PRU value by CYP2C19 genetic polymorphism at STEP 1.
3. Change in PRU value after 12 weeks.
4. Change in PRU value by CYP2C19 genetic polymorphism after 12 weeks.
5. Change in platelet-derived microparticle after 12 weeks.*
6. Incidence of bleeding and cardiovascular events.
7. Platelet-derived microparticle by CYP2C19 genetic polymorphism.*
8. Change in cytokines, such as inflammatory markers, by Bio-Plex.*
9. Change in activity of accumulated FDG (Fluoro-deoxyglucose) by PET/CT.*
*Only applicable to study participants in Kurume University Hospital
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
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 who underwent coronary artery stent implantation and have consistently treated with dual antiplatelet therapy (DAPT: clopidogrel + aspirin) over 52 weeks.
2)Patients aged 20 years or older (at the time of informed consent)
3)Patients who have provided written consent to participate in the study
4)Patients who have provided consent to collection and analysis of samples for genetic analysis
5)Patients who are able to understand the nature of the study and follow the study procedures in the opinion of the study investigator.
Key exclusion criteria
1)Patients with bleeding tendency or diathesis thereof
2)Patients with severe hepatic impairment
3)Patients with severe renal impairment
4)Patients with poorly controlled blood pressure receiving antihypertensive therapy.
5)Patients with a history of cerebral infarction or transient ischemic attack
6)Patients with a history of hypersensitivity to thienopyridine drugs such as ticlopidine, prasugrel, clopidogrel.
7)Female who are pregnant, suspected to pregnant, wish to be pregnant, or lactating.
8)Patients who are mentally incompetent (including moderate or serious dementia) and not to gain understanding and cooperation judged by Investigator
9)Patients who are hospitalized during the observation period, or needs to be hospitalized during the research period judged by Investigator.
10)Patients who need to receive treatment with prohibited concomitant drugs during the study
11)Patients disqualified from participation in the study by the principal investigator or study investigators
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Ueno |
Organization
Kurume University Hospital
Division name
Center of Cardio-vascular Disease
Zip code
8300011
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 | Takafumi |
| Middle name | |
| Last name | Ueno |
Organization
Kurume University Hospital
Division name
Center of Cardio-vascular Disease
Zip code
8300011
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
Kurume University
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
Tel
0942-31-7917
sangaku@kurume-u.ac.jp
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
久留米大学病院（福岡県）
新古賀病院（福岡県）
杉循環器科内科病院（福岡県）
九州医療センター（福岡県）
朝倉医師会病院（福岡県）
田主丸中央病院（福岡県）
福岡山王病院（福岡県）
聖マリア病院(福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 08 | 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
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | 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
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031050
