UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031864 |
|---|---|
| Receipt number | 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 | 2023/09/29 13:59:35 |
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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
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
chibaaki@hanaokaseishu.com
Sponsor or person
Institute
Hanaoka Seishu Memorial Cardiovascular Clinic
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036381
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