Last updated on June 2019

Apixaban for the Secondary Prevention of Thromboembolism Among Patients With the AntiphosPholipid Syndrome

Brief description of study

ASTRO-APS is a prospective, randomized, open-label blinded endpoint pilot study among patients with a clinical diagnosis of the AntiPhospholipid Syndrome and are already taking an anticoagulant for the secondary prevention of thrombosis (blood clots). Subjects will be randomized to receive either warfarin (target INR range 2-3) or apixaban 5 mg twice daily. Patients will follow up with the study team for 13 months. 2 in-clinic follow-up visits will be performed as well as 4 telephone follow-up visits. Study participants will be asked to consent to follow up telephone calls and questionnaires at 3 month intervals following the completion of the study procedures for the main portion of the study.

Detailed Study Description

This pilot study has two primary aims. The first is to identify patients with a clinical diagnosis of APS and then describe their recruitment, enrollment, screening failure rate, adherence to therapy, clinical characteristics, and APS diagnostic criteria in terms of broadly accepted published standards. Essential in this aim is capture of ability to identify, recruit, randomize, and retain patients with APS receiving a direct oral anticoagulant. We will also report compliance and patient satisfaction; central to durable anticoagulation management.

The second aim is to report rates of thrombosis (arterial or venous) and death caused by thrombosis, as well as major bleeding plus clinically relevant non-major bleeding over one year among APS patients randomized to either warfarin or apixaban. As such, we will report the rate of Thrombosis (arterial and/or venous) [ Time Frame: Up to 13 months after enrollment ] [ Designated as safety issue: No ] and Major and non-major bleeding [ Time Frame: Up to 13 months after enrollment ] [ Designated as safety issue: Yes ]

Clinical Study Identifier: NCT02295475

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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