UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037321 |
|---|---|
| Receipt number | R000042548 |
| Scientific Title | Investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodREsorbable-polymer drug-eluting stent: A multicenter, prospective registry from IWAte medical university affiliated hospitals |
| Date of disclosure of the study information | 2019/07/10 |
| Last modified on | 2023/08/24 12:37:29 |
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Basic information
Public title
Investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodREsorbable-polymer drug-eluting stent
Acronym
REIWA registry
Scientific Title
Investigation of clinical outcomes of patients treated with short duration dual antiplatelet therapy after implantation of biodREsorbable-polymer drug-eluting stent: A multicenter, prospective registry from IWAte medical university affiliated hospitals
Scientific Title:Acronym
REIWA registry
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate one year clinical outcomes in patients with one month dual antiplatelet(DAPT) therapy after implantation of bioresorbable polymer based drug-eluting stents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite endpointof cardiovascular death, stroke, stent thrombosis, clinically significant bleeding
Key secondary outcomes
Cardiovascular death/ MI/ stroke/ definite ST at 12 months
Major bleeding (TIMI Major/ Minor) at 12 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with successful BP-DES implantation as well as no major adverse events (death, new onset AMI, stroke, major bleeding) during hospitalization
2) Patients who can continue DAPT of aspirin and P2Y12 receptor antagonist
3) Patients with completed informed consent
Key exclusion criteria
1) patients requiring oral anticoagulant
2) patients with previous history of stent thrombosis
3)patients treated with any stents except BP-DES
4) patients known to have intolerance of P2Y12 receptor antagonist
5) patients requiring other antiplatelet agents except aspirin and P2Y12 inhibitor
6) patients who have cancer with life expectancy shorter than 2 years
7) pregnant or antcipated pregnant woman
8) patients implanted bioresorbable scaffold within 3 years
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Morino |
Organization
Iwate Medical University Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
020-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
+81-19-613-7111
ymorino@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Okuyama |
Organization
Iwate Medical University Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
020-3695
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
+81-19-613-7111
Homepage URL
yokuyama@iwate-med.ac.jp
Sponsor or person
Institute
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiology, Department of Internal Medicine, Iwate Medical University
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
Iwate Medial University School of Medicine
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
+81-19-613-7111
hiroaki.kawamori@j.iwate-med.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
| 2019 | Year | 07 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who met registration criteria and received bioresorbable polymer-based drug-eluting stent (either Synergy, Ultimaster, Orsiro), as well signed complete informed consent are enrolled to study (within 30 plus minus 3days after stent placement). Standard DAPT regimen (aspirin and thienopyridine) for 1 month followed by thienopyridine. Clinical outcomes are surveyed at 12 plus minus 1 month.
Planned number of study patients
1200 patients, at most 400 patients can be enrolled for each stent, at Iwate medical university 10 affiliated hospitals.
Primary endpoint is 12 month composite endpoint of cardiovascular death, MI, stroke, stent thrombosis, and major bleeding.
Management information
Registered date
| 2019 | Year | 07 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042548
