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Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200613
Recruitment Status : Terminated (study not feasible due to too slow recruitment)
First Posted : June 27, 2017
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sam Schulman, McMaster University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Venous Thromboembolism Drug: Apixaban Drug: Low molecular weight heparin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Open Label
Primary Purpose: Prevention
Official Title: Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apixaban
Apixaban 2.5 mg orally twice daily
Drug: Apixaban
2.5 mg orally twice daily
Other Name: 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 Name: Lovenox or Fragmin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Major Bleeding [ Time Frame: 24 months ]
    Major bleeding according to the International Society on Thrombosis and Haemostasis definition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200613


Locations
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Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Additional Information:
Publications:
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Responsible Party: Sam Schulman, Professor, McMaster University
ClinicalTrials.gov Identifier: NCT03200613    
Other Study ID Numbers: SCI Pilot RCT
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sam Schulman, McMaster University:
Spinal cord injury
Venous thromboembolism
Hemorrhage
Additional relevant MeSH terms:
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Spinal Cord Injuries
Thromboembolism
Venous Thromboembolism
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Apixaban
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors