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 |
Comparison of Platelet Aggregation Response in Switching Antiplatelet Therapy or Doses in Elder Patients After Coronary Stenting
CHAPERON
Comparison of Platelet Aggregation Response in Switching Antiplatelet Therapy or Doses in Elder Patients After Coronary Stenting
CHAPERON
Japan |
Coronary Artery Disease
Cardiology |
Others
NO
Evaluation of platelet aggregation response after switching antiplatelet therapy or doses in patients underwent percutaneous coronary intervention
Others
Evaluate platelet function by PRU (P2Y12 Reaction Units) measured by VerifyNow System
Exploratory
Pragmatic
Not applicable
Change of PRU
Death
Cardiovascular event
Bleeding event (ISTH major bleeding)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
Patients underwent Repeat coronary angiogram using dual antiplatet therapy after coronary stenting
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
400
1st name | Hiroyuki |
Middle name | |
Last name | Daida |
Juntendo University Graduate School of Medicine
Department of Cardiovascular Medicine
113-8431
3-1-3, Hongo, Bunkyo-ku, Tokyo
03-3813-3111
doies@juntendo.ac.jp
1st name | Shinichiro |
Middle name | |
Last name | Doi |
Juntendo University Graduate School of Medicine
Department of Cardiovascular Medicine
113-8431
3-1-3, Hongo, Bunkyo-ku, Tokyo
03-3813-3111
doies@juntendo.ac.jp
Juntendo University Graduate School of Medicine Department of Cardiovascular Medicine
Daiichi-Sankyo
Profit organization
Juntendo University Graduate School of Medicine, GCP center
3-1-3, Hongo, Bunkyo-ku, Tokyo
03-3813-3111
kenkyu5858@juntendo.ac.jp
NO
2017 | Year | 10 | Month | 16 | Day |
https://doi.org/10.1007/s10557-023-07454-z
Published
https://doi.org/10.1007/s10557-023-07454-z
400
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.
2023 | Year | 05 | Month | 30 | Day |
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.
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
No
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.
Completed
2017 | Year | 01 | Month | 04 | Day |
2016 | Year | 03 | Month | 17 | Day |
2018 | Year | 03 | Month | 06 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 04 | Month | 30 | Day |
We observe the change in PRU (P2Y12 Reaction Units) value.
2017 | Year | 10 | Month | 13 | Day |
2023 | Year | 06 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033395