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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name