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Clinical Trials List

Protocol NumberDSE-EDO-0l-15-EU
NCT Number(ClinicalTrials.gov Identfier)NCT02866175

2017-02-01 - 2019-05-09

Phase III

Terminated11

ICD-10I48

Atrial fibrillation and flutter

Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist-based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement. (EdoxabaN Treatment versus VKA in patients with AF undergoing PCI ( ENTRUST-AF PCI)

  • Trial Applicant

    COVANCE TAIWAN SERVICES LIMITED

  • Sponsor

    DAIICHI SANKYO EUROPE GmbH

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Kuan-Cheng Chang Division of Cardiovascular Diseases
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chern-En Chiang Division of Cardiovascular Diseases
Taipei Veterans General Hospital

Taiwan National PI

江晨恩

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Stop recruiting

Audit

None

Principal Investigator 黃建龍 Division of Cardiovascular Diseases
Cheng Hsin General Hospital

Co-Principal Investigator

  • 張鴻猷 Division of Cardiovascular Diseases
  • 曹殿萍 Division of Cardiovascular Diseases
  • 劉怡凡 Division of Cardiovascular Diseases
  • 殷偉賢 Division of Cardiovascular Diseases
  • 馮文楷 Division of Cardiovascular Diseases
  • 黃文彬 Division of Cardiovascular Diseases
  • 尤和平 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ting-Hsing Chao Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Principal Investigator 施志遠 Division of Cardiovascular Diseases
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yen-Wen Wu Division of Cardiovascular Diseases
Far Eastern Memorial Hospital

Co-Principal Investigator

  • 莊文博 Division of Cardiovascular Diseases
  • 曾炳憲 Division of Cardiovascular Diseases
  • 廖本智 Division of Cardiovascular Diseases
  • 柯欣榮 Division of Cardiovascular Diseases
  • 林恆旭 Division of Cardiovascular Diseases
  • 許榮城 Division of Cardiovascular Diseases
  • 張藝耀 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

  • 林柏霖 Division of Cardiovascular Diseases
  • 賴堯暉 Division of Cardiovascular Diseases
  • 楊翔惟 Division of Cardiovascular Diseases
  • 原博榮 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 劉俞旻 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 曾維功 Division of Cardiovascular Diseases
E-DA Hospital

Co-Principal Investigator

  • 宣錦峰 Division of Cardiovascular Diseases
  • 許寬立 Division of Cardiovascular Diseases
  • 蔡幸珊 Division of Cardiovascular Diseases
  • 施振祥 Division of Cardiovascular Diseases
  • 李統立 Division of Cardiovascular Diseases
  • 梁懷文 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Kuan-Cheng Chang 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator
Linkou Chang Gung Medical Foundation

Taiwan National PI

I-Chang Hsieh

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

1 Stop recruiting

Audit

None

Principal Investigator Tsung-Hsien Lin 未分科
Kaohsiung Municipal Gangshan Hospital

Co-Principal Investigator

Audit

None

Principal Investigator CHIA-TI TSAI Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Tsung-Hsien Lin Division of Cardiovascular Diseases
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement

Objectives

The primary objective is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12 antagonist and 1-12 months ASA in subjects with AF following successful PCI with stent placement in terms of the incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB). There are two primary hypotheses for bleeding to be tested consecutively in this study.  The edoxaban-based antithrombotic regimen is non-inferior to the VKA-based antithrombotic regimen with regards to MCRB.  The edoxaban-based antithrombotic regimen is superior to the VKA-based antithrombotic regimen with regards to MCRB. These two hypotheses are tested in a hierarchical manner, noninferiority followed by superiority to control the type-I error rate, with adequate power for each of the two hypotheses.

Test Drug

Edoxaban (DU-176b)

Active Ingredient

Edoxaban

Dosage Form

film-coated tablet
film-coated tablet
film-coated tablet

Dosage

15
30
60

Endpoints

Primary endpoint:
The primary endpoint is the composite of major or clinically relevant non-major bleeding (MCRB) defined according to the
ISTH bleeding definitions, analyzed as time to first occurrence of any component.

Secondary endpoints are defined as:
- Main efficacy endpoint (MEE), defined as the composite of
cardiovascular (CV) death, stroke, systemic embolic events
(SEE), spontaneous myocardial infarction (MI) and definite
stent thrombosis (as per ARC consensus definitions).
- Net clinical benefit (NCB), defined as the composite of CV
death, stroke, SEE, spontaneous MI, definite stent
thrombosis and ISTH-defined major bleeding.
- Main thromboembolic event, defined as composite of
cardiac or thromboembolic death, ischemic stroke, SEE,
spontaneous MI and definite stent thrombosis.
- ISTH-defined major bleeding
- Any bleeding defined as the composite of major, clinically
relevant non-major and minor bleeding (ISTH definition)
- Symptomatic intracranial hemorrhage (ICH)
- Composite of stroke and SEE
- Composite of all-cause death, stroke, SEE, spontaneous MI
and definite stent thrombosis
- Composite of CV death, spontaneous MI and definite stent
thrombosis
- The single components of the composite primary and
secondary endpoints mentioned above are explored, as well
as specific subcategories (e.g., hemorrhagic, ischemic and
undetermined stroke)
- Safety parameters such as (serious) adverse events,
laboratory parameters, ECG and vital signs.
All secondary endpoints are analyzed as time to first occurrence of
any of its components.
Bleeding events are also classified according to Bleeding
Academic Research Consortium (BARC) and Thrombolysis in
Myocardial Infarction (TIMI) classifications for descriptive
purposes only. All suspected bleeding events are adjudicated by
the CEC in a blinded manner.
All events are also sub-categorized into fatal and non-fatal.
For all endpoints blindly adjudicated by the CEC, the CEC’s
interpretation prevails and is used in the statistical analyses.

Inclution Criteria

Inclusion Criteria
OAC indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting.
Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with
stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage.
Successful PCI definition:
The success of a PCI procedure is defined by 2 interrelated components: angiographic findings,
procedural / clinical outcomes as detailed below:
Angiographic Success
A minimum stenosis diameter of < 20% (as visually assessed by angiography - residual
blockage or stenosis reduced to less than 20% of the artery’s diameter).
Sufficient enlargement of the lumen at the target site to improve coronary artery blood flow
with final TIMI flow grade 3 (visually assessed by angiography), without occlusion of a
significant side branch, flow-limiting dissection, distal embolization, or angiographic thrombus.
Procedural Success
No major in-hospital clinical complications(e.g. ongoing ISTH major or clinical relevant nonmajor procedural bleeding at the time of randomization, stroke, emergency CABG).
In summary, a clinically successful PCI requires both anatomic and procedural success along
with relief of signs and/or symptoms of myocardial ischemia at the time of randomization.

Exclusion Criteria

Exclusion Criteria
Subjects who meet any of the following criteria are disqualified from entering the study:
Bleeding risks or systemic conditions
1. Known bleeding diathesis, including but not limited to,
a. Uncontrolled active bleeding, encompassing both ISTH major and clinically
relevant non-major bleeding, preceding randomization.
b. Lesion or condition, if considered to be a significant risk for major bleeding.
This may include but is not limited to: unresolved gastrointestinal ulceration, presence of
malignant neoplasms at high risk of bleeding (e.g. malignancies with metastasis), recent
unresolved brain or spinal injury, recent brain, spinal or ophthalmic surgery, any intracranial
hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular
aneurysms (of more than 3.5 cm) or major intraspinal or intracerebral vascular abnormalities.
Medication-related
2. INR > 2.5 (the subject can be reconsidered at a later time, but within 5 days of sheath removal).
3. Contraindication to edoxaban, VKA, ASA and/or P2Y12 antagonists;
4. Concomitant treatment with other antithrombotic agents, fibrinolytic therapy and chronic
nonsteroidal anti-inflammatory drugs (NSAIDs).
Concomitant conditions and therapies
5. Critically ill or hemodynamically unstable subjects (at the time of randomization) including:
a. cardiogenic shock or acute decompensated heart failure, with the requirement for
vasopressor agents or inotropic support or mechanical support to support circulation
b. respiratory failure requiring endotracheal intubation and mechanical ventilation.
6. Any prior mechanical valvular prosthesis;
7. Planned coronary or vascular intervention or major surgery within 12 months;
Randomization must be deferred to the last stage in a multistep, multivessel PCI procedure;
8. Moderate or severe mitral stenosis;
9. Ischemic stroke within 2 weeks prior to randomization;
10. Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or
diastolic BP ≥ 120 mmHg;
11. Severe renal impairment with estimated creatinine clearance (CrCL) < 15 mL/min or on dialysis;
12. Known abnormal liver function prior to randomization (incl. hepatic disease or
biochemical evidence of significant liver derangement known prior to randomization) (see appendix 17.4).
Other exclusion criteria
13. Any of the following abnormal local laboratory results prior to randomization:
a. Platelet count < 50 x109 /L
b. Hemoglobin < 8 mg/dL
14. Unable to provide written IC;
15. Female subjects of childbearing potential without using adequate contraception (female of
childbearing potential is defined as one who has not been postmenopausal for at least one
year, or has not been surgically sterilised, or has not had a hysterectomy at least three
months prior to the start of this study [Visit 1]). Females taking oral contraceptives
should have been on therapy for at least three months. Adequate contraceptives include
hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable),
and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
16. Pregnant or breast-feeding subjects;
17. Assessment that the subject is not likely to comply with the study procedures or have
complete follow-up;
18. Participating in another clinical trial that potentially interferes with the current study;
19. Previous randomization in this study;
20. Known drug or alcohol dependence within the past 12 months as judged by the Investigator;
21. Life expectancy < 12 months.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    1500 participants

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