RECRUITINGPhase 4INTERVENTIONAL

Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis

Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 1. 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. 2. 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. 3. Able and willing to provide willing to sign a consent form. Who Should NOT Join This Trial: 1. Active bleeding or other reasons for which anticoagulation is contraindicated. 2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.). 3. 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 . 4. Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy. 5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. 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. 2. 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. 3. Able and willing to provide informed consent. Exclusion Criteria: 1. Active bleeding or other reasons for which anticoagulation is contraindicated. 2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.). 3. 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 . 4. Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy. 5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.

Treatments Being Tested

DRUG

Apixaban

Apixaban 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.

Locations (1)

The Ottawa Hospital

Ottawa, Ontario, Canada