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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031864
Receipt No. R000036381
Scientific Title Exploratory clinical study to evaluate the efficacy and safety of prasugrel monotherapy using computed tomography-derived fractional flow reserve (CT-FFR) after undergoing PCI in patients for whom long-term dual antiplatelet therapy with aspirin is not recommended
Date of disclosure of the study information 2018/04/01
Last modified on 2019/03/26

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Basic information
Public title Exploratory clinical study to evaluate the efficacy and safety of prasugrel monotherapy using computed tomography-derived fractional flow reserve (CT-FFR) after undergoing PCI in patients for whom long-term dual antiplatelet therapy with aspirin is not recommended
Acronym Exploratory clinical study to evaluate the efficacy and safety of prasugrel monotherapy using CT-FFR
Scientific Title Exploratory clinical study to evaluate the efficacy and safety of prasugrel monotherapy using computed tomography-derived fractional flow reserve (CT-FFR) after undergoing PCI in patients for whom long-term dual antiplatelet therapy with aspirin is not recommended
Scientific Title:Acronym Exploratory clinical study to evaluate the efficacy and safety of prasugrel monotherapy using CT-FFR
Region
Japan

Condition
Condition Ischemic heart disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 ・To evaluate the efficacy and safety of prasugrel monotherapy using computed tomography-derived fractional flow reserve (CT-FFR) after undergoing PCI with DES in patients for whom long-term DAPT with aspirin is not recommended.
・To evaluate the background factors of patients in whom long-term DAPT with aspirin is not recommended.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Efficacy endpoints:
-Changes in CT-FFR values before and 6 months after switching monotherapy
-Cardiovascular events
・Safety endpoints:
-Bleeding events (BARC bleeding type 2, 3, or 5)
-All adverse events
・Baseline characteristics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 ・Evaluation of blood flow by CTA (measurement of CT-FFR)/Self control
・CTA will be conducted twice (before and 6 months after switching monotherapy)
Interventions/Control_2
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 Patients are included in this study if all of the following criteria are met:
1.Patients undergoing PCI with implantation of DES
2. Patients who are not planned to receive DAPT more than 3 months after PCI with DES, and who are not medically preferable to administrate Aspirin concomitantly for long-term. (those corresponding to at least one of the following items)
(1) Patients with a history of hypersensitivity reactions to components of aspirin or to salicylic acids
(2) Patients with peptic ulcer
(3) Patients with a bleeding tendency
(4) Patients with aspirin-induced asthma (asthma attacks triggered by drugs such as NSAIDs) or a history of it
(5) Other patients in whom long-term DAPT with aspirin is medically not recommended according to an investigator (the reasons should be specified)
3. Patients who are planned to receive long-term prasugrel therapy (for at least 6 months)
4. Patients 20 years of age or older at the time of informed consent
5. Patients who provide written informed consent to their own participation in this study
Key exclusion criteria Patients are excluded from the study if they meet any one of the following exclusion criteria.
1. Patients who will require DAPT for at least 3 months after DES implantation judged by an investigator (Examples are listed below.)
Patients with the following complex lesions
(1) Triple-vessel lesions
(2) Implantation of multiple stents (>= 3 stents)
(3) A history of treatment of at least 3 lesions
(4) Implantation of 2 stents in the bifurcation
(5) Total stent length of > 60 mm
(6) Chronic total occlusions
(7) Coronary artery stents in the left main trunk
2. Patients who are treated with or planned to be treated with ticlopidine, clopidogrel, and/or cilostazol
3. Patients with bleeding risk (Hemophilia, intracranial hemorrhage, gastrointestinal hemorrhage, urinary tract hemorrhage, hemoptysis, vitreous hemorrhage, etc.)
4. Patients with a history of hypersensitivity reactions to prasugrel
5. Patients who participate or will participate in a clinical trial or clinical research involving intervention before the end of follow-up in the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Keiichi
Middle name
Last name Hanaoka
Organization Hanaoka Seishu Memorial Cardiovascular Clinic
Division name Division of Cardiovascular Medicine
Zip code 062-0003
Address Misono 3-jo 5-3-1, Toyohira, Sapporo, Hokkaido Japan
TEL 011-350-5858
Email keiichi.h.i@hanaokaseishu.com

Public contact
Name of contact person
1st name Akihiko
Middle name
Last name Chiba
Organization Hanaoka Seishu Memorial Cardiovascular Clinic
Division name Clinical Research Office
Zip code 062-0003
Address Misono 3-jo 5-3-1, Toyohira, Sapporo, Hokkaido Japan
TEL 011-350-5858
Homepage URL
Email chibaaki@hanaokaseishu.com

Sponsor
Institute Hanaoka Seishu Memorial Cardiovascular Clinic
Institute
Department

Funding Source
Organization Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Daiichi Sankyo Co., Ltd.
Name of secondary funder(s) No

IRB Contact (For public release)
Organization Joint Ethical Review Board
Address Minamikubo 1-14, Kochi, Kochi Japan
Tel 042-648-5551
Email godou-irb@epsogo.co.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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 05 Day
Date of IRB
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036381

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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