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

Last updated: May 26, 2025
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

4

Condition

Catheter Complications

Venous Thrombosis

Cancer

Treatment

Apixaban

Clinical Study ID

NCT06603870
STREAM-Line
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients (≥ 18 years old) with active cancer, defined as cancer (other thanlocalized non-melanoma skin cancer) diagnosed or treated within 6 months, or thepresence of metastatic, recurrent, or progressive malignancy, ongoing anticancertherapy, or hematological malignancy not in complete remission.

  2. Objectively confirmed catheter-related upper extremity DVT and treated with anystandard therapeutic anticoagulation (including LMWH dose reduction to 75% after thefirst month) for at least 3 months.

  3. Able and willing to provide informed consent.

Exclusion

Exclusion Criteria:

  1. Active bleeding or other reasons for which anticoagulation is contraindicated.

  2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemednecessary by treating physicians (such as atrial fibrillation, mechanical heartvalve, etc.).

  3. Anticoagulation has been permanently stopped or reduced to prophylactic dose priorto enrollment for any reasons, except for participants who were transitioned toapixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3days .

  4. Known contraindication for apixaban, such as allergy, hypersensitivity, orpregnancy.

  5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.

Study Design

Total Participants: 330
Treatment Group(s): 1
Primary Treatment: Apixaban
Phase: 4
Study Start date:
December 19, 2024
Estimated Completion Date:
October 31, 2029

Study Description

The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. 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 central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.

Connect with a study center

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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