Apixaban For Thromboprophylaxis In Patients With Acute Spinal Cord Injury
|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
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries Venous Thromboembolism||Drug: Apixaban Drug: Low molecular weight heparin||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Open Label|
|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|
Apixaban 2.5 mg orally twice daily
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 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.
- 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
- Major Bleeding [ Time Frame: 24 months ]Major bleeding according to the International Society on Thrombosis and Haemostasis definition
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200613
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|