UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047503 |
|---|---|
| Receipt number | R000054173 |
| Scientific Title | Investigation of the effect of dual antithrombotic therapy with prasugrel in patients with atrial fibrillation after drug-eluting stent implantation for coronary artery disease |
| Date of disclosure of the study information | 2022/04/18 |
| Last modified on | 2024/04/17 11:47:56 |
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Basic information
Public title
Investigation of the effect of dual antithrombotic therapy with prasugrel in patients with atrial fibrillation after drug-eluting stent implantation for coronary artery disease
Acronym
CHIBA AF-PCI registry
Scientific Title
Investigation of the effect of dual antithrombotic therapy with prasugrel in patients with atrial fibrillation after drug-eluting stent implantation for coronary artery disease
Scientific Title:Acronym
CHIBA AF-PCI registry
Region
| Japan |
Condition
Condition
Atrial fibrillation
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of dual antithrombotic therapy with oral anticoagulant and prasugrel in patients with atrial fibrillation and coronary artery disease undergoing parcutaneous coronary intervention.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiovascular events (all-cause death, non-fatal myocardial infarction, stent thrombosis, unplanned revascularization, stroke)
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients with non-valvular atrial fibrillation requiring anticoagulant therapy.
2) patients with coronary artery disease undergoing percutaneous coronary intervention.
Key exclusion criteria
1. PCI with two stent technique for bifurcation lesion
2. history of stent thrombosis
3. mechanical valve or bioprosthetic valve
4. cardiogenic shock
5. history of stroke, major surgery, gastrointestinal bleeding within 1 month
6. hemorrhagic disease or diathesis
7. severe renal dysfunction
8. severe lever dysfunction
9. allergy for warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, or prasugrel
10. pregnancy
11. scheduled for surgery
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
043-222-7171
yoshio.kobayashi@wonder.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kitahara |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
260-8677
Address
1-8-1 Inohana Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
hidekitahara0306@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine
Address
1-8-1 Inohana Chuo-ku, Chiba
Tel
043-222-7171
prc-jim@chiba-u.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
| 2022 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0914508723001387?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0914508723001387?via%3Dihub
Number of participants that the trial has enrolled
949
Results
In AF patients undergoing PCI, DAT was associated with lower incidence of MACE and major bleed- ing events compared with TAT. In comparison of P2Y12i, there might be no significant difference in the incidence of MACE and bleeding events between prasugrel-based DAT and clopidogrel-based DAT.
Results date posted
| 2024 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with AF requiring OAC therapy undergoing PCI using drug-eluting stents (DES) for coronary artery disease between January 2015 and March 2021 were screened. Main exclusion criteria were as follows: PCI with two stent technique for bifurcation lesion, history of stent thrombosis, mechanical or bioprosthetic valve, cardiogenic shock, and severe liver dysfunction. Then, a total of 949 patients were registered in this study. Patients with OAC for any indication other than AF (n = 11), no DES implantation (n = 25), lack of PCI information (n = 3), no OAC administration (n = 134), and no follow-up data after discharge (n = 30) were excluded. Furthermore, in 746 AF patients with antithrombotic therapy after PCI using DES, patients who changed from TAT to OAC alone within 1 month for no particular reason (n = 2), change in a P2Y12i during the follow-up (n = 17), and cessation of OAC without any clinical events (n = 17) were also excluded. Consequently, 710 patients were eligible for analysis in the present study.
Participant flow
The regimen and duration of antithrombotic therapies were at the discretion of attending physicians after assessment of each individual's thrombotic and bleeding risk. Patients with DAT from the time of PCI throughout the study period and those with very short-term TAT within 1 month followed by DAT were included in the DAT groups. Patients were first divided into 2 groups according to the regimen of antithrombotic therapy: DAT with P2Y12i and the remaining TAT groups. And then, patients in the DAT group were divided into 2 groups according to the type of P2Y12i for further analysis: prasugrel-based DAT (prasugrel-DAT) and clopidogrel-based DAT (clopidogrel-DAT) groups. In this analysis, the clopidogrel-DAT group included acute coronary syndrome patients receiving a loading dose of prasugrel which was then switched to maintenance dose of clopidogrel in the sub-acute phase after PCI.
Adverse events
The primary endpoint in the present study was cumulative incidence of major adverse cardiovascular events (MACE), a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, unplanned revascularization, and stroke within 1 year after PCI. The secondary safety endpoint was cumulative incidence of major bleeding events, defined as Bleeding Academic Research Consortium (BARC) types 3 and 5, within 1 year after PCI.
Outcome measures
The primary endpoint in the present study was cumulative incidence of major adverse cardiovascular events (MACE), a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, unplanned revascularization, and stroke within 1 year after PCI. The secondary safety endpoint was cumulative incidence of major bleeding events, defined as Bleeding Academic Research Consortium (BARC) types 3 and 5, within 1 year after PCI.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this observational study, patients were prospectively and retrospectively enrolled.
Management information
Registered date
| 2022 | Year | 04 | Month | 16 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054173
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