UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017410 |
|---|---|
| Receipt number | R000020195 |
| Scientific Title | Safety and Efficacy of Protocol for Shortening the Duration of Dual Antiplatelet Therapy after Second and Third Generation Drug Eluting Stent Implantation in Patients Administered Oral Anticoagulant Agent |
| Date of disclosure of the study information | 2015/05/07 |
| Last modified on | 2019/05/24 15:06:43 |
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Basic information
Public title
Safety and Efficacy of Protocol for Shortening the Duration of Dual Antiplatelet Therapy after Second and Third Generation Drug Eluting Stent Implantation in Patients Administered Oral Anticoagulant Agent
Acronym
Safety and Efficacy of Protocol for Shortening the Duration of Dual Antiplatelet Therapy after Second and Third Generation Drug Eluting Stent Implantation in Patients Administered Oral Anticoagulant Agent
Scientific Title
Safety and Efficacy of Protocol for Shortening the Duration of Dual Antiplatelet Therapy after Second and Third Generation Drug Eluting Stent Implantation in Patients Administered Oral Anticoagulant Agent
Scientific Title:Acronym
Safety and Efficacy of Protocol for Shortening the Duration of Dual Antiplatelet Therapy after Second and Third Generation Drug Eluting Stent Implantation in Patients Administered Oral Anticoagulant Agent
Region
| Japan |
Condition
Condition
Consecutive patients with coronary artery disease who were administered oral anticoagulant agent
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of protocol for shortening the duration of dual antiplatelet therapy after second and third generation drug eluting stent implantation in patients who were administered oral anticoagulant agent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Composite of major adverse events (death, acute coronary syndrome, stroke, any revascularization and systemic embolism), and hemorrhagic complication measured by BARC
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One month duration of aspirin after drug eluting implantation in patients who were administered oral anticoagulant therapy
Interventions/Control_2
Conventional DAPT in patients who were not administered anticoagulant therapy
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
1. Patients with coronary artery disease who were treated with second and third generation drug eluting stent
2. Patients with concomitant administration of oral anticoagulation agent
3. Patients over the age of 20
4. Patients who were obtained written informed consent
Key exclusion criteria
1. Patients who could not tolerate antiplatelet therapy or anticoagulation therapy
2. Patients who appeared to be inappropriate for this study, determined by the investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Inoue |
Organization
Sendai Kousei Hospital
Division name
Cadiovascular Division
Zip code
9800873
Address
4-15, Hirose-cho, Sendai, Miyagi, Japan
TEL
+81-22-222-6181
inouena@est.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Horie |
Organization
Sendai Kousei Hospital
Division name
Cardiovascular Division
Zip code
9800873
Address
4-15, Hirose-cho, Sendai, Miyagi, Japan
TEL
+81-22-222-6181
Homepage URL
horihori1015@gmail.com
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai Kousei Hospital
Address
4-15, Hirose, Aoba, Sendai, Miyagi, Japan
Tel
+81222226181
heartcenter@st.cat-v.ne.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
| 2015 | Year | 05 | Month | 07 | 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
285
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
Main results already published
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 03 | Day |
Last modified on
| 2019 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020195
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/12/04 | 抗凝固デザイン, DAPT + OAC.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/05/06 | DAPT in AF, UMIN.xlsx |
