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

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Sep 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how to best manage patients with cancer who have developed a specific type of blood clot in their arm due to a catheter, which is a tube used for treatment. After patients have been on blood-thinning medication for three months, the trial will look at what happens next and whether continuing treatment with a medication called apixaban helps prevent further blood clots.

To be eligible for the trial, participants must be adults with active cancer and have been diagnosed with a catheter-related blood clot in their arm, treated with blood thinners for at least three months. Participants should be able to give their consent to join the study. It's important to note that those with active bleeding, certain health conditions, or specific allergies to the medication will not be able to participate. If you join the trial, you'll be closely monitored to see how this management strategy works for your health.

Gender

ALL

Eligibility criteria

• 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.