Spinal Cord InjuriesPhase 2NCT03200613
Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury
A Phase 2 study testing Apixaban and Low molecular weight heparin in people with Spinal Cord Injuries and Venous Thromboembolism, run by McMaster University at 1 site in Canada.
Trial summary
Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Venous Thromboembolism
- What is being tested?
- Apixaban and Low molecular weight heparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Adult patients (≥18 years old) with acute spinal cord injury (SCI) presenting to the hospital within 1 week of SCI and is at least 36 h after the injury
- Traumatic SCI
- SCI with or without other injuries
Who cannot join
- Already on therapeutic oral anticoagulation prior to enrollment
- Active bleeding, intracranial or perispinal hematoma, or acquired or congenital bleeding disorder
- Pregnancy or breast feeding
- Severe renal failure (creatinine clearance ≤30 ml/min)
- Liver cirrhosis
- Severe thrombocytopenia (platelets <50)
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- Attending physician believes that the patient is not suitable for the study (for example, psychiatric disorder; history of non-compliance)
- Geographic inaccessibility: planned transfer to other site where follow-up not possible
- Failure to obtain written consent
- Previous hypersensitivity reaction to study drugs
- Patients with expected short hospital admission (≤7 days) due to minor injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study
Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this population. Participants will be randomized to apixaban 2.5 mg twice daily or standard dose low-molecular-weight heparin (LMWH), either enoxaparin 40 mg or dalteparin 5000 units, subcutaneously once daily for 90 days or until fully mobilized, whatever comes first. Thromboprophylaxis will be started as soon as hemostasis is achieved. The primary outcome for this pilot study will be the recruitment rate per year (i.e. the screened to enrolled ratio). The primary efficacy endpoint will be a composite of symptomatic, objectively verified, venous thromboembolism (VTE), defined as upper or lower limb deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or sudden death where PE cannot be excluded. The primary safety endpoint will be major bleeding.
Read the detailed description
Patients with acute (SCI) have a high risk of VTE despite thromboprophylaxis. The current standard thrombprophylaxis is to use LMWH fas soon as hemostasis is achieved. The duration of thromboprophylaxis is commonly 3 months. This entails once or twice daily subcutaneous injections of LMWH for the patients for this duration, which is inconvenient for the patients. There are currently no studies on use of DOACs for thromboprophylaxis in patients with SCI.
We will perform a pilot study at Hamilton General on apixaban versus LMWH for thromboprophylaxis in patients with acute SCI. Upon providing written informed consent, eligible patients will be randomized to apixaban 2.5 mg twice daily or LMWH, either enoxaparin 40 mg or dalteparin 5000 units, subcutaneously once daily for 90 days or until fully mobilized, whatever comes first.
The primary outcome for the feasibility study will be the recruitment rate per year (i.e. the screened to enrolled ratio). Other key feasibility measures will be accrual ratio, protocol violations pertaining to eligibility criteria and randomization procedures, retention rate for primary end-point assessment at 1 year, and the estimates of endpoint rates in the population. The primary efficacy endpoint will be a composite of symptomatic, objectively verified VTE (upper or lower limb DVT and/or PE) or sudden death where PE cannot be excluded. The primary safety endpoint will be major bleeding.
This will be the first study comparing the use of LMWH against a DOAC in SCI patients. Use of a DOAC such as apixaban can eliminate the burden associated with daily injections for the patients.
- Conditions
- Spinal Cord Injuries, Venous Thromboembolism
- Being tested
- Apixaban, Low molecular weight heparin
- Keywords
- Spinal cord injury, Venous thromboembolism, Hemorrhage
- Medical subject headings
- Spinal Cord Injuries, Venous Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called Eliquis
2.5 mg orally twice daily
Low molecular weight heparinDrug
Also called Lovenox or Fragmin
Dalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | Apixaban 2.5 mg orally twice daily Receives: Drug: Apixaban |
| Low Molecular Weight Heparin | Active comparator | Either enoxaparin 40 mg or dalteparin 5000 units subcutaneously once daily Receives: Drug: Low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary feasibility outcome: recruitment rate per year (i.e. the screened to enrolled ratio)
The investigators define success as the ability to identify 20 eligible patients at each center per 12-month period.
Measured: 24 months
Secondary outcomes (2)
Composite of Symptomatic Venous Thromboembolism or Sudden Death Where Pulmonary Embolism Cannot be Excluded
A composite of symptomatic, objectively verified VTE (upper or lower limb DVT and/or PE) or sudden death where PE cannot be excluded
Measured: 24 months
Major Bleeding
Major bleeding according to the International Society on Thrombosis and Haemostasis definition
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Sep 2017
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Why it stopped: study not feasible due to too slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Schulman, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200613
- Sponsor's protocol ID
- SCI Pilot RCT
- Status last verified
- Feb 2020
- First submitted
- 21 Jun 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Piran S, Schulman S. Incidence and risk factors for venous thromboembolism in patients with acute spinal cord injury: A retrospective study. Thromb Res. 2016 Nov;147:97-101. doi: 10.1016/j.thromres.2016.09.030. Epub 2016 Oct 3.
PubMed 27721141Piran S, Schulman S. Thromboprophylaxis in Patients with Acute Spinal Cord Injury: A Narrative Review. Semin Thromb Hemost. 2019 Mar;45(2):150-156. doi: 10.1055/s-0039-1678720. Epub 2019 Feb 11.
PubMed 30743281
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study
- ClinicalTrials.gov ID
- NCT03200613
- Acronym / sponsor ID
- SCI Pilot RCT
- Conditions
- Spinal Cord Injuries, Venous Thromboembolism
- Keywords
- Spinal cord injury, Venous thromboembolism, Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study not feasible due to too slow recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 27 Jun 2017 (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.
Thromboprophylaxis options are limited for patients with acute spinal cord injury (SCI) and there are no studies on direct oral anticoagulants (DOACs) for thromboprophylaxis in this population. Participants will be randomized to apixaban 2.5 mg twice daily or standard dose low-molecular-weight heparin (LMWH), either enoxaparin 40 mg or dalteparin 5000 units, subcutaneously once daily for 90 days or until fully mobilized, whatever comes first. Thromboprophylaxis will be started as soon as hemostasis is achieved. The primary outcome for this pilot study will be the recruitment rate per year (i.e. the screened to enrolled ratio). The primary efficacy endpoint will be a composite of symptomatic, objectively verified, venous thromboembolism (VTE), defined as upper or lower limb deep vein thrombosis (DVT) and/or pulmonary embolism (PE) or sudden death where PE cannot be excluded. The primary safety endpoint will be major bleeding.
Detailed description
Patients with acute (SCI) have a high risk of VTE despite thromboprophylaxis. The current standard thrombprophylaxis is to use LMWH fas soon as hemostasis is achieved. The duration of thromboprophylaxis is commonly 3 months. This entails once or twice daily subcutaneous injections of LMWH for the patients for this duration, which is inconvenient for the patients. There are currently no studies on use of DOACs for thromboprophylaxis in patients with SCI.
We will perform a pilot study at Hamilton General on apixaban versus LMWH for thromboprophylaxis in patients with acute SCI. Upon providing written informed consent, eligible patients will be randomized to apixaban 2.5 mg twice daily or LMWH, either enoxaparin 40 mg or dalteparin 5000 units, subcutaneously once daily for 90 days or until fully mobilized, whatever comes first.
The primary outcome for the feasibility study will be the recruitment rate per year (i.e. the screened to enrolled ratio). Other key feasibility measures will be accrual ratio, protocol violations pertaining to eligibility criteria and randomization procedures, retention rate for primary end-point assessment at 1 year, and the estimates of endpoint rates in the population. The primary efficacy endpoint will be a composite of symptomatic, objectively verified VTE (upper or lower limb DVT and/or PE) or sudden death where PE cannot be excluded. The primary safety endpoint will be major bleeding.
This will be the first study comparing the use of LMWH against a DOAC in SCI patients. Use of a DOAC such as apixaban can eliminate the burden associated with daily injections for the patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: ApixabanApixaban 2.5 mg orally twice daily |
| Low Molecular Weight Heparin | Active comparator | Drug: Low molecular weight heparinEither enoxaparin 40 mg or dalteparin 5000 units subcutaneously once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years old) with acute spinal cord injury (SCI) presenting to the hospital within 1 week of SCI and is at least 36 h after the injury
- Traumatic SCI
- SCI with or without other injuries
Key exclusion criteria (11 listed)
- Already on therapeutic oral anticoagulation prior to enrollment
- Active bleeding, intracranial or perispinal hematoma, or acquired or congenital bleeding disorder
- Pregnancy or breast feeding
- Severe renal failure (creatinine clearance ≤30 ml/min)
- Liver cirrhosis
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 |
|---|---|---|
| ApixabanAlso: Eliquis2.5 mg orally twice daily | Drug | Apixaban |
| Low molecular weight heparinAlso: Lovenox or FragminDalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily | Drug | Low Molecular Weight Heparin |
Primary outcome
Primary feasibility outcome: recruitment rate per year (i.e. the screened to enrolled ratio)
Time frame: 24 months
The investigators define success as the ability to identify 20 eligible patients at each center per 12-month period.
2 secondary outcomes
Composite of Symptomatic Venous Thromboembolism or Sudden Death Where Pulmonary Embolism Cannot be Excluded
Time frame: 24 months
Major Bleeding
Time frame: 24 months
Results and safety
The study was stopped early (reason given: study not feasible due to too slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 27721141Piran S, Schulman S. Incidence and risk factors for venous thromboembolism in patients with acute spinal cord injury: A retrospective study. Thromb Res. 2016 Nov;147:97-101. doi: 10.1016/j.thromres.2016.09.030. Epub 2016 Oct 3.
- Background: PubMed 30743281Piran S, Schulman S. Thromboprophylaxis in Patients with Acute Spinal Cord Injury: A Narrative Review. Semin Thromb Hemost. 2019 Mar;45(2):150-156. doi: 10.1055/s-0039-1678720. Epub 2019 Feb 11.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apixaban and Low molecular weight heparin in people with Spinal Cord Injuries and Venous Thromboembolism, run by McMaster University at 1 site in Canada.
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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Feb 2020. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: study not feasible due to too slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary feasibility outcome: recruitment rate per year (i.e. the screened to enrolled ratio) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200613, which also lists 2 linked publications.
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 20 Feb 2020.