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Last Updated: November 2, 2024

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CLINICAL TRIALS PROFILE FOR SAVAYSA


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All Clinical Trials for SAVAYSA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02561897 ↗ EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation Terminated Axio Research Corporation Phase 4 2015-12-01 This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
NCT02561897 ↗ EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation Terminated Electrophysiology Research Foundation Phase 4 2015-12-01 This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
NCT02567461 ↗ Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel Completed Daiichi Sankyo Inc. Phase 4 2016-03-01 It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02567461 ↗ Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel Completed Daiichi Sankyo, Inc. Phase 4 2016-03-01 It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02567461 ↗ Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel Completed University of Florida Phase 4 2016-03-01 It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SAVAYSA

Condition Name

Condition Name for SAVAYSA
Intervention Trials
Atrial Fibrillation 6
Coronary Artery Disease 1
Deep Vein Thrombosis (DVT) 1
Intracerebral Hemorrhage 1
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Condition MeSH

Condition MeSH for SAVAYSA
Intervention Trials
Atrial Fibrillation 6
Hemorrhage 2
Hemostatic Disorders 1
Coronary Disease 1
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Clinical Trial Locations for SAVAYSA

Trials by Country

Trials by Country for SAVAYSA
Location Trials
United States 74
Japan 12
United Kingdom 10
Spain 8
Canada 7
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Trials by US State

Trials by US State for SAVAYSA
Location Trials
California 4
Florida 4
New Jersey 3
Washington 3
Virginia 3
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Clinical Trial Progress for SAVAYSA

Clinical Trial Phase

Clinical Trial Phase for SAVAYSA
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 1
[disabled in preview] 2
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Clinical Trial Status

Clinical Trial Status for SAVAYSA
Clinical Trial Phase Trials
Completed 6
Recruiting 4
Terminated 1
[disabled in preview] 0
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Clinical Trial Sponsors for SAVAYSA

Sponsor Name

Sponsor Name for SAVAYSA
Sponsor Trials
Daiichi Sankyo Inc. 3
Daiichi Sankyo, Inc. 3
Chiltern International Inc. 2
[disabled in preview] 3
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Sponsor Type

Sponsor Type for SAVAYSA
Sponsor Trials
Other 51
Industry 13
[disabled in preview] 0
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