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Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury

NCT03200613 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-20

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Venous Thromboembolism

Interventions

DRUG

Apixaban

2.5 mg orally twice daily

DRUG

Low molecular weight heparin

Dalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-07-01
Completion
2019-08-01

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03200613 on ClinicalTrials.gov