Warfarin versus Edoxaban for Treatment of Deep Vein Thrombosis (DVT) in Patients with Severe Motor Intellectual Disabilities (SMID)

UMIN ID: UMIN000024736

Registered date:14/11/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Severe Motor and Intellectual Disabilities
• Date of first enrollment: 2016/11/14
• Target sample size: 76
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Warfarin group: After diagnosis of DVT, start administration of Warfarin orally.
Edoxaban group: After diagnosis of DVT, start administration of Edoxaban orally.

Outcome(s)

• Primary Outcome: 1) Cross sectional Study Incidence of DVT,Risk factors of DVT 2) Open-label Randomaized Trial of DVT Primary End-point Safety Outcome during on-treatment : major or clinically relevant nonmajor bleeding
• Secondary Outcome: Thrombotic burden assessment including size, location and number of DVT on venous ultrasound -Changes of coagulation markers -Bleeding in routine care for SMID patients -Incidences of adverse event for the study period -Exploratory end point -Frequency of measurement of PT-INR in warfarin group -Frequency of dosage adjustments for warfarin -Time in therapeutic INR range in warfarin group

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study. 2) Patients with calculated creatinine clearance of less than 15 ml per minute 3)Patients receiving contraindicated agents for study drugs.

Related Information

• Primary Sponsor: National Hospital Organization Yanai Medical Center
• Source(s) of Monetary Support: National Hospital Organization