Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Sponsor

Loewenstein Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05484557

Collaborator

(none)

Enrollment

Arms

30.1

Anticipated Duration (Months)

Study Details

Study Description

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 end of the treatment. Bleeding events will be recorded and hematocrit will be monitored every two weeks.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Spinal Diseases	Drug: Apixaban Drug: Enoxaparin Sodium	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study treatment with Apixaban	Drug: Apixaban treatment for 6 to 12 weeks
Active Comparator: Control treatment with Enoxaparin	Drug: Enoxaparin Sodium treatment for 6 to 12 weeks

Arm

Intervention/Treatment

Experimental: study

treatment with Apixaban

Drug: Apixaban

treatment for 6 to 12 weeks

Active Comparator: Control

treatment with Enoxaparin

Drug: Enoxaparin Sodium

treatment for 6 to 12 weeks

Outcome Measures

Primary Outcome Measures

Number of participants with venous thromboembolism (VTE) [2 years]
deep vein thrombosis or pulmonary embolism

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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