UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029541 |
|---|---|
| Receipt number | R000033395 |
| Scientific Title | Comparison of Platelet Aggregation Response in Switching Antiplatelet Therapy or Doses in Elder Patients After Coronary Stenting |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2023/06/03 05:55:18 |
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Basic information
Public title
Comparison of Platelet Aggregation Response in Switching Antiplatelet Therapy or Doses in Elder Patients After Coronary Stenting
Acronym
CHAPERON
Scientific Title
Comparison of Platelet Aggregation Response in Switching Antiplatelet Therapy or Doses in Elder Patients After Coronary Stenting
Scientific Title:Acronym
CHAPERON
Region
| Japan |
Condition
Condition
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of platelet aggregation response after switching antiplatelet therapy or doses in patients underwent percutaneous coronary intervention
Basic objectives2
Others
Basic objectives -Others
Evaluate platelet function by PRU (P2Y12 Reaction Units) measured by VerifyNow System
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of PRU
Key secondary outcomes
Death
Cardiovascular event
Bleeding event (ISTH major bleeding)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 underwent Repeat coronary angiogram using dual antiplatet therapy after coronary stenting
Key exclusion criteria
1 Patients who survive within 1 year
2 Patients who are indicated for revascularization such as percutaneous coronary intervention or bypass
3 Patients who are judged inappropriate inthis trial by director
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Daida |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
doies@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Doi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
doies@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi-Sankyo
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Graduate School of Medicine, GCP center
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
https://doi.org/10.1007/s10557-023-07454-z
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1007/s10557-023-07454-z
Number of participants that the trial has enrolled
400
Results
Switching from clopidogrel 75 mg to prasugrel 2.5 mg significantly lowered and aggregated the PRU value. Whereas, dose reduction of prasugrel had a significantly lower proportion of bleeding risk over one year after PCI than the continuation of prasugrel 3.75 mg, and was an independent predictor for bleeding risk with reference of continuation of prasugrel 3.75 mg.
Results date posted
| 2023 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was designed as a dual-center, observational, prospective cohort study at Juntendo hospital and Juntendo Shizuoka hospital. We enrolled patients with coronary artery disease who underwent PCI between 2017 and 2020. We excluded patients who met the following criteria; patients who were expected to survive within one year, patients who were indicated for revascularization by enrollment in this study, patients who were judged inappropriate or did not agree to this study, and patients who failed to procure a baseline blood sample.
Participant flow
We studied 400 patients who underwent PCI between 2017 and 2020. We excluded two patients who failed to obtain a baseline blood sample, and 50 patients who had not taken any P2Y12 inhibitors, thus, 348 patients were included in this study
Adverse events
No
Outcome measures
In this study, primary analysis compared the proportion of bleeding risk and ischemic risk according to PRU values at baseline and follow-up. Bleeding risk was defined as low platelet reactivity (PRU<85), and ischemic risk was defined as high platelet reactivity (PRU>239). Secondary assessments were included as follows: 1) the comparison of changes in the average PRU value at baseline and follow-up, 2) the comparison of changes in the average PRU value when switching from clopidogrel 75 mg to prasugrel 2.5 mg, or from prasugrel 3.75 mg to prasugrel 2.5 mg, and 3) the incidence of Bleeding Academic Research Con- sortium (BARC) type 3 or 5 bleeding events, and all-cause death.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We observe the change in PRU (P2Y12 Reaction Units) value.
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033395
