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Recruiting NCT06603870

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

Phase IV Interventional Venous Thromboembolism Cancer Upper Extremity Deep Vein Thrombosis Catheter-Related Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apixaban.
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Cancer, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed 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.

Interventions

  • 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 s

Primary outcome measures

  • Venous Thromboembolism (VTE) Rate [Time frame: 6 months]
Secondary outcome measures (11)
  • Major Venous Thromboembolism (VTE) and Major bleeding Rate [Time frame: 3 months]
  • New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT). [Time frame: 3 months and 6 months]
  • New incidental Venous Thromboembolism (VTE) [Time frame: 3 months and 6 months]
  • New Deep Vein Thrombosis (DVT) [Time frame: 3 months and 6 months]
  • Superficial vein thrombosis of upper or lower extremities [Time frame: 3 months and 6 months]
  • New unusual site Venous Thromboembolism (VTE) [Time frame: 3 months and 6 months]
  • Clinically Relevant Non-Major Bleeding (CRNMB) events [Time frame: 3 months and 6 months]
  • Arterial thromboembolic events [Time frame: 3 months and 6 months]
  • All-cause mortality [Time frame: 3 months and 6 months]
  • Correlative biomarkers [Time frame: 6 months]
  • Health-related quality of life using the EuroQoL-5D-5L Questionnaire [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • The Ottawa Hospital — Ottawa

Identifiers

NCT: NCT06603870 · STREAM-Line

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗