Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON)
NCT ID: NCT04010955
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1200 participants
OBSERVATIONAL
2019-10-08
2026-06-27
Brief Summary
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Detailed Description
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Edoxaban reduced bleeding complication compared to warfarin in patients with atrial fibrillation. In addition, the ENGAGE AF TIMI-48 study showed a tendency to reduce cerebral infarction (p for interaction = 0.08) when administered in combination with one antiplatelet agent and edoxaban. The administration of antiplatelet agents may be due to patients had accompanying myocardial infarction or cerebral infarction. This group is also thought to have a high risk of bleeding due to high HAS-BLED scores. Nonetheless, there was a similar degree of bleeding in patients receiving additional antiplatelet agents. There was also less bleeding in the warfarin arm than in the use of additional antiplatelet agents. (Major bleeding: 0.19 vs 0.24% / yr; intracranial hemorrhage: 0.43 vs 0.57% / yr)
Thus, Edoxaban have good clinical trial results in combination with antiplatelet agents in atrial fibrillation with atherosclerosis compared to other NOACs(new oral anticoagulants). It is also considered to be suitable for combination therapy with antiplatelet agents because of its advantages in different bleeding compared to other warfarin. However, there is no evidence to suggest that Edoxaban alone or in combination with additional antiplatelet agents is better for stroke patients with atrial fibrillation and significant arteriosclerosis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Edoxaban Monotherapy
edoxaban monotherapy without additional antiplatelet therapy in long term stroke prevention.
However, transient additional antiplatelet therapy will be allowed at the discretion of duty physicians.
Edoxaban Monotherapy
when the patients will be initially registered in this study, duty physicians will make a decision to give additional antiplatelet therapy in addition to standard edoxaban therapy.
Edoxaban and antiplatelet combination
edoxaban plus additional antiplatelet therapy in long term stroke prevention. However, transient cessation of antiplatelet therapy will be allowed at the discretion of duty physicians.
Edoxaban Monotherapy
when the patients will be initially registered in this study, duty physicians will make a decision to give additional antiplatelet therapy in addition to standard edoxaban therapy.
Interventions
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Edoxaban Monotherapy
when the patients will be initially registered in this study, duty physicians will make a decision to give additional antiplatelet therapy in addition to standard edoxaban therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with non-valvular atrial fibrillation including paroxysmal atrial fibrillation which is eligible for treatment with Edoxaban.
3. Patients with significant atherosclerosis confirmed by imaging tests on the cerebral arteries, coronary arteries, or peripheral arteries and suitable for the use of antiplatelet agents.
* Significant intracranial internal stenosis confirmed by CTA or MRA
* A history of coronary artery disease, meaningful findings from CTA or CAG Arterial stenosis
* Peripheral arterial disease (Ankle-Brachial Index, ABI \<0.9, significant stenosis found in lower limb ultrasonography
3\) Men and women over 20 years old 4) Patients who voluntarily agreed to register the registry
Exclusion Criteria
2. patients requiring warfarin medication due to prosthetic valve replacement
3. patients with internal bleeding (active internal bleeding)
4. bleeding diathesis
5. History of acute myocardial infarction or received coronary artery procedure within 6 months before screening
6. Patients who have received or are scheduled to undergo carotid stenting within 1 year
7. Currently, two or more antiplatelet agents are required due to arteriosclerosis.
8. Patients whose survival period is expected to be less than 12 months due to serious diseases such as terminal cancer or liver failure
9. Patients who are scheduled for invasive surgery with possible uncontrolled bleeding, including major surgery
10. Women who are pregnant or lactating, do not have contraception during the study
11. A person who is found to be unsuitable for participation in the study due to the clinical laboratory test results or other reasons
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Myongji Hospital
OTHER
Ewha Womans University
OTHER
Chonbuk National University
OTHER
Pusan National University Hospital
OTHER
Korea University Ansan Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Chonnam National University Hospital
OTHER
Korea University Guro Hospital
OTHER
Chungnam National University Hospital
OTHER
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Kyungpook National University Hospital
OTHER
Dongtan Sacred Heart Hospital
OTHER
Eulji University Hospital
OTHER
Asan Medical Center
OTHER
Responsible Party
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Sun U. Kwon
Professor
Principal Investigators
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Sun U. Kwon, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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References
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Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med. 2010 Jul;123(7):638-645.e4. doi: 10.1016/j.amjmed.2009.11.025.
Willeit K, Pechlaner R, Egger G, Weger S, Oberhollenzer M, Willeit J, Kiechl S. Carotid atherosclerosis and incident atrial fibrillation. Arterioscler Thromb Vasc Biol. 2013 Nov;33(11):2660-5. doi: 10.1161/ATVBAHA.113.302272. Epub 2013 Sep 12.
Kanter MC, Tegeler CH, Pearce LA, Weinberger J, Feinberg WM, Anderson DC, Gomez CR, Rothrock JF, Helgason CM, Hart RG. Carotid stenosis in patients with atrial fibrillation. Prevalence, risk factors, and relationship to stroke in the Stroke Prevention in Atrial Fibrillation Study. Arch Intern Med. 1994 Jun 27;154(12):1372-7.
Chang YJ, Ryu SJ, Lin SK. Carotid artery stenosis in ischemic stroke patients with nonvalvular atrial fibrillation. Cerebrovasc Dis. 2002;13(1):16-20. doi: 10.1159/000047740.
Lehtola H, Airaksinen KEJ, Hartikainen P, Hartikainen JEK, Palomaki A, Nuotio I, Ylitalo A, Kiviniemi T, Mustonen P. Stroke recurrence in patients with atrial fibrillation: concomitant carotid artery stenosis doubles the risk. Eur J Neurol. 2017 May;24(5):719-725. doi: 10.1111/ene.13280. Epub 2017 Mar 20.
Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.
Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
Fisher M. Does the combination of warfarin and aspirin have a place in secondary stroke prevention? No. Stroke. 2009 May;40(5):1944-5. doi: 10.1161/STROKEAHA.108.537670. Epub 2009 Mar 19. No abstract available.
Kim BJ, Kim HJ, Do Y, Lee JH, Park KY, Cha JK, Kim HY, Kwon JH, Lee KB, Kim DE, Ha SW, Sohn SI, Kwon SU. The impact of prior antithrombotic status on cerebral infarction in patients with atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 Sep;23(8):2054-2059. doi: 10.1016/j.jstrokecerebrovasdis.2014.03.011. Epub 2014 Aug 10.
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.
Kim BJ, Kang HG, Lee DH, Kang DW, Kim JS, Kwon SU. Ischemic stroke on optimal anticoagulation with novel-oral anticoagulants compared with warfarin. Int J Stroke. 2015 Aug;10(6):E68. doi: 10.1111/ijs.12587. No abstract available.
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.
Perez-Gomez F, Alegria E, Berjon J, Iriarte JA, Zumalde J, Salvador A, Mataix L; NASPEAF Investigators. Comparative effects of antiplatelet, anticoagulant, or combined therapy in patients with valvular and nonvalvular atrial fibrillation: a randomized multicenter study. J Am Coll Cardiol. 2004 Oct 19;44(8):1557-66. doi: 10.1016/j.jacc.2004.05.084.
Ois A, Cuadrado-Godia E, Rodriguez-Campello A, Giralt-Steinhauer E, Jimenez-Conde J, Lopez-Cuina M, Ley M, Soriano C, Roquer J. Relevance of stroke subtype in vascular risk prediction. Neurology. 2013 Aug 6;81(6):575-80. doi: 10.1212/WNL.0b013e31829e6f37. Epub 2013 Jul 3.
Kang K, Park TH, Kim N, Jang MU, Park SS, Park JM, Ko Y, Lee S, Lee KB, Lee J, Kim DE, Cho YJ, Kim JT, Kim DH, Cha JK, Han MK, Lee JS, Lee J, Oh MS, Choi JC, Lee BC, Hong KS, Bae HJ. Recurrent Stroke, Myocardial Infarction, and Major Vascular Events during the First Year after Acute Ischemic Stroke: The Multicenter Prospective Observational Study about Recurrence and Its Determinants after Acute Ischemic Stroke I. J Stroke Cerebrovasc Dis. 2016 Mar;25(3):656-64. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.036. Epub 2015 Dec 29.
Other Identifiers
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Add-on_001
Identifier Type: -
Identifier Source: org_study_id
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