Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Diseases; Spinal Cord Injuries
• Intervention / Treatment: Drug: Apixaban; Drug: Enoxaparin Sodium

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amiram Catz, MD PhD; Phone Number: 972-9-770-9934; Email: amiramc@clalit.org.il

Study Locations

• Israel
  • Ra'anana, Israel
    • Recruiting
    • Loewenstein Rehabilitation Hospital
    • Contact: Sara Lipkin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Loewenstein Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: July 24, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2025
• Last Update Submitted That Met QC Criteria: May 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Thromboembolism; Spinal Cord Injuries; Spinal Diseases; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Enoxaparin sodium; Enoxaparin; Apixaban
• Other Study ID Numbers: 0023-20-LOE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No