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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05122455
Other study ID # SDC 5189/20/218
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 14, 2021
Est. completion date December 30, 2025

Study information

Verified date June 2023
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rationale: The interaction between nonvitamin K oral anticoagulants (NOACs) and platelet aggregation is complex. The direct activated factor X inhibitors (factor Xa inhibitors) an NOAC antagonizes thrombin generation, one of most important platelet agonist, so that, factor Xa inhibitors has a potential effect in decreasing thrombin-mediated platelet aggregation. On the other hand, patients who experience ACS continue to have a hypercoagulable state for long periods after the index event. The COMPASS trial showed that, in patients with stable coronary artery disease (SCAD), Rivaroxaban (a direct anti-Xa inhibitor) in addition to antiplatelet agent, compared to antiplatelet therapy alone, reduced the composite endpoint of myocardial infarction, stroke and death. Objective: Analyze the role of edoxaban on platelet aggregation in SCAD patients. Methods and Results: This is a prospective, non-randomized, interventional study of SCAD patients taking low-dose acetylsalicylic acid (ASA). Subjects initially will receive in the following sequence: ASA 100 mg once daily (QD) plus edoxaban 60 mg QD, clopidogrel 75 mg QD alone, clopidogrel 75 mg QD plus edoxaban 60 mg QD, and edoxaban 60 mg QD alone. Platelet function will be assessed by standard of care technology, at baseline and after each intervention phase, by Multiplate-ADP® (primary endpoint), Multiplate-Aspi® and Multiplate-TRAP®. In addition to immature platelets fraction (% IPF) and count (IPC). Coagulability will be assessed, at baseline and after each intervention phase, by thromboelastogram (TEG) assessment. Specifically, after the phases in which edoxaban will be administered activated factor X (FXa) level and Plasminogen activator inhibitor-1 (PAI-1) will be evaluated in addition to previous. Finally, inflammatory markers will be, at same way, assessed at baseline and after intervention each phase: ultrasensitive C-reactive protein (us-PCR). Keywords: edoxaban, direct factor Xa inhibitor, stable coronary artery disease, aspirin, clopidogrel, platelet aggregation.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Brazil Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo Sao Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Daiichi Sankyo, Inc.

Country where clinical trial is conducted

Brazil, 

References & Publications (24)

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Outcome

Type Measure Description Time frame Safety issue
Other Other secondary goals Total immature platelets (IPC) and fractions (%IPF), and inflammatory markers: ultrasensitive CRP after each intervention phase.
Thromboelastography (TEG) after each intervention phase.
Dosing of plasminogen activator inhibitor type 1 (PAI-1) and factor Xa activity after each intervention phase in which edoxaban is administered.
Analyze the primary objective of the study in the following subgroups:
Gender (male/female);
Diabetes (presence or not);
Current or not smoking;
Elderly (= 65 years old) and non-elderly.
24 months
Primary Main objective: To compare platelet aggregability in patients with CAD using the Multiplate-TRAP® method at the start of ASA use and after 10 ± 2 days of the association of edoxaban and ASA. 24 months
Secondary Platelet reactivity after edoxaban plus ASA vs ASA To compare of platelet aggregability measured by Multiplate-ADP®, Multiplate-Aspi® at baseline and after 10 ± 2 days of edoxaban and ASA. 24 months
Secondary Platelet reactivity after edoxaban plus Clopidogrel vs Clopidogrel To compare of platelet aggregability measured by Multiplate-ADP®, Multiplate-Aspi® and Multiplate-TRAP® before and after 10 ± 2 days of edoxaban and clopidogrel compared to clopidogrel alone; 24 months
Secondary Platelet reactivity after edoxaban vs after ASA To compare of platelet aggregability measured by Multiplate-ADP®, Multiplate-Aspi® and Multiplate-TRAP® before and after 10 ± 2 days of edoxaban only compared to ASA only; 24 months
Secondary Platelet reactivity after edoxaban vs after Clopidogrel To compare of platelet aggregability measured Multiplate-ADP®, Multiplate-Aspi® and Multiplate-TRAP® before and after 10 ± 2 days of edoxaban only compared to clopidogrel alone; 24 months
Secondary Platelet reactivity after edoxaban plus ASA vs after edoxaban plus Clopidogrel To compare of platelet aggregability measured Multiplate-ADP®, Multiplate-Aspi® and Multiplate-TRAP® before and after 10 ± 2 days of edoxaban plus clopidogrel compared to 10 ± 2 days of edoxaban and AAS. 24 months
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