Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05484557

Enrollment

Registered

2022-08-02

Start date

2023-09-06

Completion date

2028-02-01

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries, Spinal Diseases

Brief summary

Currently, Enoxaparin is the usual prophylactic anticoagulant treatment at the acute and sub-acute phases of spinal cord injury (SCI). Patients at the sub-acute phase of SCI (rehabilitation) will be given either Enoxaparin 40 mg/day (control) or Apixaban 2.5-5 mg twice a day. Apixaban dose will be determined by the treating physician. Treatment will be continued for either 6 or 12 weeks following injury (for AIS grades C-D and A-B respectively). Endpoints: Venous thromboembolism will be evaluated by D-Dimer test every 2 weeks and an ultrasound doppler at the beginning and the end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.

Interventions

DRUGApixaban

treatment for 6 to 12 weeks

DRUGEnoxaparin Sodium

treatment for 6 to 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* spinal cord injury (traumatic of not traumatic), Hebrew speaker.

Exclusion criteria

* contra-indication for anticoagulant treatment * concomitant treatment with any other anticoagulant * anticoagulant treatment needed for indications other than VTE prevention following spinal cord injury * active clinically significant bleeding * any lesion or condition considered a significant risk factor for major bleeding. * hepatic disease associated with coagulopathy and clinically relevant bleeding risk * pregnancy or breast-feeding * heart valve related issues * galactose intolerance * active cancer * patients who require thrombolysis or pulmonary embolectomy * patients with renal impairment * sensitivity to excipients of the medication * anti phospholipid syndrome * prosthetic heart valve * acute ischemic stroke

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with venous thromboembolism (VTE)	2 years	deep vein thrombosis or pulmonary embolism

Secondary

Measure	Time frame	Description
Number of participants with bleeding events.	6 to 12 weeks	bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.

Countries

Israel

Contacts

CONTACTAmiram Catz, MD PhD

amiramc@clalit.org.il972-9-770-9934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026