UMIN-CTR Clinical Trial

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015923
Receipt No. 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 (Ver. 7)

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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
Email 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
Email hoshi.tm@md.tsukuba.ac.jp

Sponsor
Institute Cardiovascular Division, Faculty of Medicine, University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017636