Clinical trial NCT00781391: Global Study to Assess the Safety and Effectiveness of Edoxaban (DU-176b) vs Standard Practice of Dosing With Warfarin in Patients With Atrial Fibrillation
Official title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Atrial Fibrillation
Embolism
Keywords: Systemic embolic events
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: The TIMI Study Group
First posted: 2008-10-29
Enrollment: 21105
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, \& Warfarin. The expected duration of the study is 24 months.


Eligibility criteria: Inclusion Criteria:

* 21 years of age or older; male or female.
* Able to provide written informed consent.
* History of documented AF within the prior 12 months
* A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria:

* Transient atrial fibrillation secondary to other reversible disorders
* Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
* Subjects with any contraindication for anticoagulant agents;
* Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
* Females of childbearing potential including the following:

  * Females with a history of tubal-ligation
  * Females less than 2 years post-menopausal

Primary outcomes:
measure: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
timeFrame: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
timeFrame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
timeFrame: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE).
timeFrame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE).
timeFrame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Secondary outcomes:
measure: Compare Edoxaban to Warfarin for Composite of Stroke, Systemic Embolic Event (SEE), and Cardiovascular (CV) Mortality
timeFrame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Compare Edoxaban to Warfarin for Major Adverse Cardiac Event (MACE): a Composite of Non-fatal MI, Non-fatal Stroke, Non-fatal SEE, and Death Due to CV Cause or Bleeding
timeFrame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Compare Edoxaban to Warfarin for Composite of Stroke, SEE, and All-cause Mortality
timeFrame: overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up
measure: Adjudicated Bleeding Events
timeFrame: on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up
Other outcomes:
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state: Kyoto
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state: Nagano
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state: Tokyo
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city: Chiba
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city: Hokkai-do
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city: Hokkaido
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city: Guadalajara
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state: Veracruz
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city: Umea
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country: Taiwan
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city: Nakhon Ratchasima
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city: Pathumthani
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city: Sai Mai
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country: Thailand
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city: Antalya
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city: Aydin
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city: Erzurum
country: Turkey
city: Eskisehir
country: Turkey
city: Isparta
country: Turkey
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country: Turkey
city: Izmir
country: Turkey
city: Konya
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country: Turkey
city: Cherkasy
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city: Chernigiv
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city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsh
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: Lugansk
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Mykolayiv
country: Ukraine
city: Odesa
country: Ukraine
city: Poltava
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Birmingham
country: United Kingdom
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country: United Kingdom
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country: United Kingdom
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country: United Kingdom
city: Cambridge
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: Coventry
country: United Kingdom
city: Devon
country: United Kingdom
city: Dundee
country: United Kingdom
city: East Horsley
country: United Kingdom
city: East Sussex
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Essex
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrow
country: United Kingdom
city: Leicester
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Orpington
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Portadown
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stirling
country: United Kingdom
city: Stockport
country: United Kingdom
city: Surrey
country: United Kingdom
city: Sutton Coldfield
country: United Kingdom
city: Swindon
country: United Kingdom
city: Warwickshire
country: United Kingdom
city: Wolverhampton
country: United Kingdom
city: York
country: United Kingdom
Study officials:
References:
citation: Bonaca MP, Antman EM, Cunningham JW, Wiviott SD, Murphy SA, Halperin JL, Weitz JI, Grosso MA, Lanz HJ, Braunwald E, Giugliano RP, Ruff CT. Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706. doi: 10.1093/ehjcvp/pvab089.
citation: Oyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141.
citation: Steffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053.
citation: Wilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w.
citation: Vilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5.
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