Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury

February 18, 2020 updated by: Sam Schulman, McMaster University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apixaban
Apixaban 2.5 mg orally twice daily
Drug: Apixaban
2.5 mg orally twice daily
Other Names:
  • Eliquis
Active Comparator: Low Molecular Weight Heparin
Either enoxaparin 40 mg or dalteparin 5000 units subcutaneously once daily
Drug: Low molecular weight heparin
Dalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily
Other Names:
  • Lovenox or Fragmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of Symptomatic Venous Thromboembolism or Sudden Death Where Pulmonary Embolism Cannot be Excluded
Time Frame: 24 months
A composite of symptomatic, objectively verified VTE (upper or lower limb DVT and/or PE) or sudden death where PE cannot be excluded
24 months
Major Bleeding
Time Frame: 24 months
Major bleeding according to the International Society on Thrombosis and Haemostasis definition
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI Pilot RCT

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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