This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).
Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.
Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.
Able and willing to provide informed consent.
Active bleeding or other reasons for which anticoagulation is contraindicated.
Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
Anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days .
Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy.
Single group
Apixaban
DrugApixaban is Health Canada approved for routine treatment and secondary prevention of VTE. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a CVC or active cancer is present. Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Patients will be instructed to contact the study team when their CVC is removed (to determine if apixaban should be continued, based on cancer status at the time), or any thrombotic or bleeding concerns were to occur in between visits. The investigators will record loss to follow-up, drop out, or death during the study.
Venous Thromboembolism (VTE) Rate
The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months.
Major Venous Thromboembolism (VTE) and Major bleeding Rate
Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months.
New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
New/recurrent symptomatic catheter-related upper extremity DVT.
New incidental Venous Thromboembolism (VTE)
New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans.
New Deep Vein Thrombosis (DVT)
New/recurrent any distal upper or lower extremity DVT or subsegmental PE.
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