UMIN-CTR Clinical Trial

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
Last 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
1st 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