Spinal Cord InjuriesNCT05484557
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
A study testing Apixaban and Enoxaparin Sodium in people with Spinal Cord Injuries and Spinal Diseases, run by Loewenstein Hospital at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Diseases
- What is being tested?
- Apixaban and Enoxaparin Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Sep 2023to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spinal cord injury (traumatic of not traumatic), Hebrew speaker.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Rehabilitation Hospital
Raanana
Sara Lipkin
About this study
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.
- Conditions
- Spinal Cord Injuries, Spinal Diseases
- Being tested
- Apixaban, Enoxaparin Sodium
- Medical subject headings
- Spinal Cord Injuries, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
treatment for 6 to 12 weeks
Enoxaparin SodiumDrug
treatment for 6 to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | treatment with Apixaban Receives: Drug: Apixaban |
| Control | Active comparator | treatment with Enoxaparin Receives: Drug: Enoxaparin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with venous thromboembolism (VTE)
deep vein thrombosis or pulmonary embolism
Measured: 2 years
Secondary outcomes (1)
Number of participants with bleeding events.
bleeding occurrence (decrease of hemoglobin by at least 1 g/dL) during the medication period.
Measured: 6 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start6 Sep 2023
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amiram-catz, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484557
- Sponsor's protocol ID
- 0023-20-LOE
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05484557
- Acronym / sponsor ID
- 0023-20-LOE
- Conditions
- Spinal Cord Injuries, Spinal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: Apixabantreatment with Apixaban |
| Control | Active comparator | Drug: Enoxaparin Sodiumtreatment with Enoxaparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- spinal cord injury (traumatic of not traumatic), Hebrew speaker.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixabantreatment for 6 to 12 weeks | Drug | study |
| Enoxaparin Sodiumtreatment for 6 to 12 weeks | Drug | Control |
Primary outcome
Number of participants with venous thromboembolism (VTE)
Time frame: 2 years
deep vein thrombosis or pulmonary embolism
1 secondary outcome
Number of participants with bleeding events.
Time frame: 6 to 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apixaban and Enoxaparin Sodium in people with Spinal Cord Injuries and Spinal Diseases, run by Loewenstein Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amiram Catz, MD PhD (972-9-770-9934, amiramc@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with venous thromboembolism (VTE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.