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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027089
Receipt No. 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

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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
Email 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
Email takueno@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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