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Comparison of Efficacy and Safety Among Dabigatran, Rivaroxaban, and Apixaban in Non-Valvular Atrial Fibrillation (DARING-AF)

Primary Purpose

Atrial Fibrillation

Status

Unknown status

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

Dabigatran etexilate

Rivaroxaban

Apixaban

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, systemic embolism, bleeding, oral anticoagulant

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Known AF (paroxysmal or persistent/ permanent) who are suitable and ready for NOAC treatment plus at least one of the following criteria

Prior ischemic stroke, transient ischemic accident or systemic embolism
Left ventricular ejection fraction ≤40% (documented by echocardiography or contrast ventriculography)
Symptomatic congestive heart failure (≥ New York Heart Association Functional Class 2) within 6 months before screening
Age ≥75 years
Age ≥65 but <75 years with diabetes mellitus, hypertension or coronary artery disease

Exclusion Criteria: Subjects are excluded if they have at least one of the following situations before screening:

Known severe (i.e. hemodynamically significant) mitral stenosis regardless of having received operation
Time elapsed from the onset of stroke ≤7 days
Bleeding tendency
Creatinine clearance rate ≤30 mL/min
Known active liver disease (persistent elevation of alanine aminotransferase, aspartate transaminase or alkaline phosphatase ≥3 × upper normal limit; or advanced liver cirrhosis ≥Pugh B)
Pregnancy
Recent documented active malignancy or radiation therapy (≤6 months) and not expected to survive 3 years
Unwilling to give informed consent
Conditions other than AF that required anticoagulation
Anemia (hemoglobin level <90 g/L) or thrombocytopenia (platelet count <100 × 109/L)
Persistent uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg)
Active infective endocarditis
Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trial because of concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study

Sites / Locations

National Cheng Kung University HospitalRecruiting
Tainan Hospital Ministry of Health and Welfare
National Cheng Kung University Hospital Dou-Liou Branch
E-DA Hospital
Tainan Municipal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Dabigatran

Rivaroxaban

Apixaban

Arm Description

oral dabigatran etexilate capsule 110 or 150 mg (110 mg in specific population) bid for entire study period

oral rivaroxaban film-coated tablet 15 or 20 mg (10 or 15 mg in specific population) qd for entire study period

oral apixaban 5 mg (2.5 mg in specific population) bid for entire study period

Outcomes

Primary Outcome Measures

Time to the occurrence of the major embolic events

a composite of stroke (ischemic or hemorrhagic), transient ischemic attack or systemic embolism

Secondary Outcome Measures

Time to the occurrence of the major embolic events and death

a composite of all stroke (including hemorrhagic), systemic embolism, and death

Time to the occurrence of the major embolic and vascular events

a composite of all stroke, systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death

Time to the occurrence of all clinically relevant bleeding events

a composite of major bleeding or clinically relevant non-major bleeding events

Full Information

NCT ID

NCT02666157

First Posted

January 24, 2016

Last Updated

February 14, 2016

Sponsor

National Cheng-Kung University Hospital

Collaborators

Tainan Municipal Hospital, E-DA Hospital, National Cheng-Kung University Hospital Dou-Liou Branch, Ministry of Health and Welfare, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT02666157

Brief Title

Comparison of Efficacy and Safety Among Dabigatran, Rivaroxaban, and Apixaban in Non-Valvular Atrial Fibrillation

Acronym

DARING-AF

Official Title

Comparison of Efficacy and Safety Among DAbigatran, RIvaroxaban, and ApixabaN in Patients HavinG Non-Valvular Atrial Fibrillation in Taiwan (DARING-AF Study)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

Collaborators

Tainan Municipal Hospital, E-DA Hospital, National Cheng-Kung University Hospital Dou-Liou Branch, Ministry of Health and Welfare, Taiwan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The recent development of novel oral anticoagulants (NOACs), including direct thrombin inhibitor (dabigatran) and factor Xa inhibitors (rivaroxaban, apixaban, and edoxaban), could potentially overcome many drawbacks of warfarin, and might provide a safer, and even more effective and convenient alternative approach to warfarin in non-valvular atrial fibrillation (NVAF), especially in Asians. According to the results of a meta-analysis comparing Asians and non-Asians, NOACs are preferentially indicated in Asians in terms of both efficacy and safety. There is no randomized controlled trial with sufficient power to directly compare the efficacy and safety among NOACs in NVAF, not to speak of Asians and Chinese. Indirect comparisons are only based on observation with a lot of limitations such as heterogeneous background characteristics, difference in study design, and diversity in time within therapeutic range in control group. The findings from indirect comparisons are not conclusive but only hypothesis-generating. This investigator-initiated prospective randomized open blinded end-point clinical trial will directly compare the efficacy and safety among 3 NOACs in patients with NVAF in Taiwan. We hypothesize that rivaroxaban or apixaban is non-inferior to dabigatran in terms of the efficacy.

Detailed Description

participants a. eligible participants are randomly assigned to dabigatran, rivaroxaban, or apixaban with allocation ratio of 1:1:1 Patients are randomly assigned to receive dabigatran (110 or 150 mg twice daily), rivaroxaban (15 or 20 mg daily), or apixaban (5 mg twice daily) with dosage and frequency approved by the Ministry of Health and Welfare, Taiwan. Reduced doses (dabigatran 110 mg twice daily, rivaroxaban 10 or 15 mg daily, or apixaban 2.5 mg twice daily) are allowed in a subset of patients with one or more of the following criteria: an age of at least 80 years, a body weight of no more than 60 kg, a serum creatinine level ≥1.5 mg per deciliter (133 μmol per liter) or creatinine clearance around 30 to 49 ml per minute) blood sampling, genotyping, and measurement of biomarkers a. bood samples (13 mL) from peripheral veins in all study subjects at baseline and 10 mL 3 months later, and stored for enzyme-linked immunosorbent assay as well as genotyping outcome follow-up a. clinical follow-up is performed and clinical outcomes are obtained by clinic visit, telephone call or direct contact with participants or subjects' family quarterly after treatment for 2 times, then every 6 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

atrial fibrillation, stroke, systemic embolism, bleeding, oral anticoagulant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3672 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dabigatran

Arm Type

Active Comparator

Arm Description

oral dabigatran etexilate capsule 110 or 150 mg (110 mg in specific population) bid for entire study period

Arm Title

Rivaroxaban

Arm Type

Active Comparator

Arm Description

oral rivaroxaban film-coated tablet 15 or 20 mg (10 or 15 mg in specific population) qd for entire study period

Arm Title

Apixaban

Arm Type

Active Comparator

Arm Description

oral apixaban 5 mg (2.5 mg in specific population) bid for entire study period

Intervention Type

Drug

Intervention Name(s)

Dabigatran etexilate

Other Intervention Name(s)

Pradaxa

Intervention Description

this drug is administered twice per day for the entire study period

Intervention Type

Drug

Intervention Name(s)

Rivaroxaban

Other Intervention Name(s)

Xarelto

Intervention Description

this drug is administered once per day for the entire study period

Intervention Type

Drug

Intervention Name(s)

Apixaban

Other Intervention Name(s)

Eliquis

Intervention Description

this drug is administered twice per day for the entire study period

Primary Outcome Measure Information:

Title

Time to the occurrence of the major embolic events

Description

a composite of stroke (ischemic or hemorrhagic), transient ischemic attack or systemic embolism

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Time to the occurrence of the major embolic events and death

Description

a composite of all stroke (including hemorrhagic), systemic embolism, and death

Time Frame

up to 36 months

Title

Time to the occurrence of the major embolic and vascular events

Description

a composite of all stroke, systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death

Time Frame

up to 36 months

Title

Time to the occurrence of all clinically relevant bleeding events

Description

a composite of major bleeding or clinically relevant non-major bleeding events

Time Frame

up to 36 months

Other Pre-specified Outcome Measures:

Title

Time to the occurrence of all stroke

Description

stroke is defined as a focal loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death

Time Frame

up to 36 months

Title

Time to the occurrence of systemic embolism

Description

embolic events excluding stroke, pulmonary embolism or venous thromboembolism

Time Frame

up to 36 months

Title

Time to the occurrence of transient ischemic attack

Description

a transient focal loss of neurological function caused by an ischemic event with complete recovery within 24 hours after onset

Time Frame

up to 36 months

Title

Time to the occurrence of death

Description

all-cause death includes vascular and non-vascular causes

Time Frame

up to 36 months

Title

Time to the occurrence of pulmonary embolism

Description

clinical diagnosis of pulmonary embolism should be confirmed by an image study

Time Frame

up to 36 months

Title

Time to the occurrence of acute myocardial infarction

Description

acute myocardial infarction is defined in accordance with the universal definition proposed in 2012

Time Frame

up to 36 months

Title

Time to the occurrence of vascular death

Description

sudden cardiac death, fatal stroke, fatal myocardial infarction, any other death for which there is no clearly documented non-vascular cause, and death from bleeding

Time Frame

up to 36 months

Title

Time to the occurrence of hospitalization for congestive heart failure

Description

decompensated congestive heart failure requiring hospitalization for stabilization

Time Frame

up to 36 months

Title

Time to the occurrence of advanced chronic kidney disease

Description

defined as estimated glomerular filtration rate <30 mL/min/1.73m2 confirmed by 2 separate laboratory tests within 3 months

Time Frame

up to 36 months

Title

Time to the occurrence of cardiogenic shock

Description

symptoms and signs of organ hypoperfusion (e.g. cool peripheries, oliguria) plus one of the following parameters: systolic blood pressure 90 mmHg or less, hypotension requiring inotropic/vasopressor therapy remaining after fluid challenge, heart rate of at least 60 bpm, or a cardiac index of 2.2 L/min/m2 or less

Time Frame

up to 36 months

Title

Time to the occurrence of any revascularization for peripheral artery disease

Description

percutaneous transluminal angioplasty or bypass surgery for low extremity artery disease

Time Frame

up to 36 months

Title

Time to the occurrence of any revascularization for coronary artery disease

Description

percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary artery disease

Time Frame

up to 36 months

Title

Time to occurrence of any revascularization for carotid or vertebral artery stenosis

Description

endovascular therapy, endarterectomy or bypass surgery for carotid or vertebral artery stenosis

Time Frame

up to 36 months

Title

Time to the occurrence of major bleeding events

Description

defined as bleeding to cause a drop in hemoglobin level >= 2g/dL, fatal bleeding, life-threatening bleeding, or symptomatic bleeding at critical sites (including intracranial, retroperitoneal, intraocular, or intrapericardial)

Time Frame

up to 36 months

Title

Time to the occurrence of life-threatening bleeding events

Description

defined as fatal bleeding, symptomatic intracranial hemorrhage, bleeding to cause a drop in hemoglobin level >=5g/dL, bleeding requiring transfusion with >=4u blood component, bleeding requiring vasopressor administration, or bleeding needing surgery for hemostasis

Time Frame

up to 36 months

Title

Time to the occurrence of minor bleeding events

Description

non-major or non-life-threatening bleeding events

Time Frame

up to 36 months

Title

Time to the occurrence of clinically relevant non-major bleeding events

Description

clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to hospital admission, physician-guided medical or surgical treatment, or a change in antithrombotic therapy

Time Frame

up to 36 months

Title

Time to the occurrence of major or minor bleeding events

Description

major or minor bleeding

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Known AF (paroxysmal or persistent/ permanent) who are suitable and ready for NOAC treatment plus at least one of the following criteria Prior ischemic stroke, transient ischemic accident or systemic embolism Left ventricular ejection fraction ≤40% (documented by echocardiography or contrast ventriculography) Symptomatic congestive heart failure (≥ New York Heart Association Functional Class 2) within 6 months before screening Age ≥75 years Age ≥65 but <75 years with diabetes mellitus, hypertension or coronary artery disease Exclusion Criteria: Subjects are excluded if they have at least one of the following situations before screening: Known severe (i.e. hemodynamically significant) mitral stenosis regardless of having received operation Time elapsed from the onset of stroke ≤7 days Bleeding tendency Creatinine clearance rate ≤30 mL/min Known active liver disease (persistent elevation of alanine aminotransferase, aspartate transaminase or alkaline phosphatase ≥3 × upper normal limit; or advanced liver cirrhosis ≥Pugh B) Pregnancy Recent documented active malignancy or radiation therapy (≤6 months) and not expected to survive 3 years Unwilling to give informed consent Conditions other than AF that required anticoagulation Anemia (hemoglobin level <90 g/L) or thrombocytopenia (platelet count <100 × 109/L) Persistent uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg) Active infective endocarditis Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trial because of concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ting-Hsing Chao, MD

Phone

886-6-2353535

Ext

2382

chaoth@mail.ncku.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ting-Hsing Chao, MD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

National Cheng Kung University Hospital

City

Tainan

State/Province

Tainan City

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ting-Hsing Chao, MD

Phone

886-6-2353535

Ext

2382

chaoth@mail.ncku.edu.tw

First Name & Middle Initial & Last Name & Degree

Ting-Hsing Chao, MD

First Name & Middle Initial & Last Name & Degree

Ju-Yi Chen, MD and PhD

First Name & Middle Initial & Last Name & Degree

Cheng-Han Lee, MD and PhD

First Name & Middle Initial & Last Name & Degree

Chih-Chan Lin, MD

First Name & Middle Initial & Last Name & Degree

Chih-Hung Chen, MD

First Name & Middle Initial & Last Name & Degree

Liang-Miin Tsai, MD

First Name & Middle Initial & Last Name & Degree

Li-Jen Lin, MD

First Name & Middle Initial & Last Name & Degree

Wei-Chuan Tsai, MD

First Name & Middle Initial & Last Name & Degree

Ping-Yen Liu, MD and PhD

Facility Name

Tainan Hospital Ministry of Health and Welfare

City

Tainan

State/Province

Tainan City

ZIP/Postal Code

704

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Li-Dan Yang, MD

Phone

886-6-2200055

Ext

litannyang@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

Li-Dan Yang, MD

Facility Name

National Cheng Kung University Hospital Dou-Liou Branch

City

Dou-Liou City

ZIP/Postal Code

640

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang-Cheh Hsueh, MD

Phone

886-5-5332121

Ext

5101

p308378@dou6.hosp.ncku.edu.tw

First Name & Middle Initial & Last Name & Degree

Yang-Cheh Hsueh, MD

First Name & Middle Initial & Last Name & Degree

Yuen-Ting Sung, MD and PhD

Facility Name

E-DA Hospital

City

Kaohsiung

ZIP/Postal Code

824

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei-Kung Tseng, MD and PhD

Phone

886-7-6150011

Ext

5005

arthurtseng@me.com

First Name & Middle Initial & Last Name & Degree

Wei-Kung Tseng, MD and PhD

Facility Name

Tainan Municipal Hospital

City

Tainan

ZIP/Postal Code

701

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

I-Chih Chen, MD

Phone

886-6-2609926

Ext

212045

ichih1230@yahoo.com.tw

First Name & Middle Initial & Last Name & Degree

I-Chih Chen, MD

First Name & Middle Initial & Last Name & Degree

Ruei-Chang Zeng, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22240753

Citation

Chiang CE, Zhang S, Tse HF, Teo WS, Omar R, Sriratanasathavorn C. Atrial fibrillation management in Asia: from the Asian expert forum on atrial fibrillation. Int J Cardiol. 2013 Mar 20;164(1):21-32. doi: 10.1016/j.ijcard.2011.12.033. Epub 2012 Jan 10.

Results Reference

background

PubMed Identifier

24500243

Citation

Chiang CE, Wang KL, Lip GY. Stroke prevention in atrial fibrillation: an Asian perspective. Thromb Haemost. 2014 May 5;111(5):789-97. doi: 10.1160/TH13-11-0948. Epub 2014 Feb 6.

Results Reference

background

PubMed Identifier

18840379

Citation

Lin LJ, Cheng MH, Lee CH, Wung DC, Cheng CL, Kao Yang YH. Compliance with antithrombotic prescribing guidelines for patients with atrial fibrillation--a nationwide descriptive study in Taiwan. Clin Ther. 2008 Sep;30(9):1726-36. doi: 10.1016/j.clinthera.2008.09.010.

Results Reference

background

PubMed Identifier

24642004

Citation

Chang CH, Yang YH, Chen JH, Lin LJ. Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in atrial fibrillation in Taiwan. Thromb Res. 2014 May;133(5):782-9. doi: 10.1016/j.thromres.2014.02.024. Epub 2014 Mar 3.

Results Reference

background

PubMed Identifier

25463377

Citation

Lip GY, Wang KL, Chiang CE. Non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in Asian patients with atrial fibrillation: time for a reappraisal. Int J Cardiol. 2015 Feb 1;180:246-54. doi: 10.1016/j.ijcard.2014.11.182. Epub 2014 Nov 26.

Results Reference

background

PubMed Identifier

19717844

Citation

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum In: N Engl J Med. 2010 Nov 4;363(19):1877.

Results Reference

background

PubMed Identifier

21830957

Citation

Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.

Results Reference

background

PubMed Identifier

21870978

Citation

Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.

Results Reference

background

PubMed Identifier

24251359

Citation

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

Results Reference

background

PubMed Identifier

23743976

Citation

Hori M, Connolly SJ, Zhu J, Liu LS, Lau CP, Pais P, Xavier D, Kim SS, Omar R, Dans AL, Tan RS, Chen JH, Tanomsup S, Watanabe M, Koyanagi M, Ezekowitz MD, Reilly PA, Wallentin L, Yusuf S; RE-LY Investigators. Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation. Stroke. 2013 Jul;44(7):1891-6. doi: 10.1161/STROKEAHA.113.000990. Epub 2013 Jun 6.

Results Reference

background

PubMed Identifier

24315724

Citation

Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4.

Results Reference

background

PubMed Identifier

22575324

Citation

Lip GY, Larsen TB, Skjoth F, Rasmussen LH. Indirect comparisons of new oral anticoagulant drugs for efficacy and safety when used for stroke prevention in atrial fibrillation. J Am Coll Cardiol. 2012 Aug 21;60(8):738-46. doi: 10.1016/j.jacc.2012.03.019. Epub 2012 May 9.

Results Reference

background

PubMed Identifier

19376304

Citation

Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2. doi: 10.1016/j.ahj.2009.02.005.

Results Reference

background

PubMed Identifier

20211293

Citation

ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.

Results Reference

background

PubMed Identifier

20211292

Citation

Lopes RD, Alexander JH, Al-Khatib SM, Ansell J, Diaz R, Easton JD, Gersh BJ, Granger CB, Hanna M, Horowitz J, Hylek EM, McMurray JJ, Verheugt FW, Wallentin L; ARISTOTLE Investigators. Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale. Am Heart J. 2010 Mar;159(3):331-9. doi: 10.1016/j.ahj.2009.07.035. Erratum In: Am Heart J. 2010 Jun;159(6):1162.

Results Reference

background

PubMed Identifier

20934556

Citation

Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41. doi: 10.1016/j.ahj.2010.06.042.

Results Reference

background

PubMed Identifier

26304863

Citation

Wang KL, Lip GY, Lin SJ, Chiang CE. Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Asian Patients With Nonvalvular Atrial Fibrillation: Meta-Analysis. Stroke. 2015 Sep;46(9):2555-61. doi: 10.1161/STROKEAHA.115.009947. Epub 2015 Jul 30.

Results Reference

background

Learn more about this trial

Comparison of Efficacy and Safety Among Dabigatran, Rivaroxaban, and Apixaban in Non-Valvular Atrial Fibrillation

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