UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015923 |
|---|---|
| Receipt number | R000017636 |
| Scientific Title | Safety and Effectiveness Trial of Apixaban Use in Association with Dual Antiplatelet Therapy in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2020/03/05 21:43:27 |
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Basic information
Public title
Safety and Effectiveness Trial of Apixaban Use in Association with Dual Antiplatelet Therapy in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention
Acronym
SAFE-A
Scientific Title
Safety and Effectiveness Trial of Apixaban Use in Association with Dual Antiplatelet Therapy in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym
SAFE-A
Region
| Japan |
Condition
Condition
Patients with atrial fibrillation undergoing percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and effectiveness of concomitant administration of apixaban and short-duration dual antiplatelet treatment
in patients with atrial fibrillation who underwent drug-eluting stent implantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Any bleeding events: TIMI(Major/Minor), BARC, or blood transfusion
Key secondary outcomes
1. Composite events of all-cause death, myocardial infarction, stroke, or systemic embolization
2. Net clinical benefit of all-cause death, myocardial infarction, stroke, or systemic embolization, and bleeding complications (BARC type 3 or higher)
3. Individual endpoints
(1)All-cause death
(2)Cardiovascular death
(3)Non-cardiovascular death
(4)Myocardial infarction
(5)Unstable angina
(6)Stroke
(7)Systemic embolization
(8)Stent thrombosis
(9)Coronary revascularization
(10)Surgery
(11)CABG
(12)Heart failure
(13)Discontinuation of anticoagulant or antiplatelet treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 months duration of clopidgrel
(1 months triple therapy with aspirin, clopidpgrel, and apixaban)
Interventions/Control_2
6 months duration of clopidgrel
(6 months triple therapy with aspirin, clopidpgrel, and apixaban)
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 non-valvular atrial fibrillation
2. Patients with coronary artery disease who underwent drug-eluting stent implantation
3. Patients with concomitant administration of apixaban and dual antiplatelet treatment (aspirin and clopidogrel)
4. Patients with 20 years and over
5. Patients with CHADS2-Vasc score of 1 and over
6. Patients who were obtained written informed consent
Key exclusion criteria
1. Patients who cannot tolerate antiplatelets and anticoagulants
2. Patients after mechanical valve replacement
3. Patients in whom a stent has been placed in the left main trunk
4. Patients in whom stents have been placed in a bifurcated lesion by the two stent technique
5. Patients complicated with decompensated heart failure or cardiogenic shock
6. Patients complicated with advanced chronic kidney disease (creatinine clearance <15 ml/min)
7. Patients with a past history of intracranial hemorrhage
8. Patients with a past history of stent thrombosis
9. Patients for whom surgery (cardiac and noncardiac surgery) is scheduled
10. Patients for whom pulmonary vein isolation is scheduled
11. Patients with active hemorrhage
12. Patients with active malignant tumor
13. Patients with pregnancy
14. Patients who are not expected to live 1 year or longer
15. Patients deemed to be inappropriate as the subjects of this study by the investigator
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
kaonuma@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Hoshi |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Cardiovascular Division
Zip code
Address
1-1-1, Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
Homepage URL
hoshi.tm@md.tsukuba.ac.jp
Sponsor or person
Institute
Cardiovascular Division, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
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
Address
Tel
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 | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0914508716301344?via%3Dihub
Publication of results
Unpublished
Result
URL related to results and publications
https://eurointervention.pcronline.com/article/short-duration-triple-antithrombotic-therapy-for-atri
Number of participants that the trial has enrolled
210
Results
Primary endpoint
all bleeding: 1 month vs 6 months; 11.8% vs 16.0% (Log-rank, P=0.34)
Secondary endpoint
Composite events (all-cause death, myocardial infarction, stroke, systemic embolization): 1 month vs 6 months; 9.8% vs 2.8% (Log-rank, P=0.053)
Net Clinical Benefit (all-cause death, myocardial infarction, stroke, systemic embolization, bleeding with BARC type 3 or higher): 1 month vs 6 months; 10.8% vs 5.7% (Log-rank, P=0.22)
Results date posted
| 2019 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age: 1 month, 73.2 years, 6 months, 72.1 years
Male: 1 month, 78%, 6 months, 80%
Other baseline characteristics were not significantly different.
Participant flow
Between December 2015 and March 2018, a total of 210 eligible patients from 66 participating centers in Japan were enrolled in the study. After excluding seven patients (two who withdrew consent, one who did not take the study drug, and four who deviated from the study protocol), our analysis included 210 patients who completed the trial (1-month group, 102 patients; 6-month group, 106 patients).
Adverse events
1 month 34%, 6 months 46%, P=0.091
Outcome measures
Primary endpoint
Any bleeding complications within 12 months: TIMI (Major/Minor), BARC, or blood transfusion
Secondary endpoints
1. Composite events within 12 months: all-cause death, myocardial infarction, stroke, or systemic embolization
2. Net clinical benefit within 12 months: all-cause death, myocardial infarction, stroke, or systemic embolization and bleeding complications (BARC type 3 or higher)
3. Individual endpoints within 12 months
(1) All-cause death
(2) Cardiac death and vascular death
(3) Non-cardiac death
(4) Myocardial infarction
(5) Hospitalization due to unstable angina
(6) Stroke
(7) Systemic embolization
(8) Stent thrombosis
(9) Coronary revascularization by PCI
(10) Surgery
(11) CABG
(12) Emergent hospitalization due to heart failure
(13) Unscheduled dose reduction or discontinuation of study drugs
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017636
