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NCT Number: NCT06603870

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

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).

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Key information

Conditions

Venous Thromboembolism Cancer Cardiovascular Diseases Catheter-Related Infections Embolism and Thrombosis Infections Neoplasms Thromboembolism Thrombosis Upper Extremity Deep Vein Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location status: Recruiting

Location contact

Tania Salvi

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apixaban

Drug

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.

Primary outcomes

  1. Venous Thromboembolism (VTE) Rate

    Time frame: 6 months

    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.

Secondary outcomes

  1. Major Venous Thromboembolism (VTE) and Major bleeding Rate

    Time frame: 3 months

    Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months.

  2. New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).

    Time frame: 3 months and 6 months

    New/recurrent symptomatic catheter-related upper extremity DVT.

  3. New incidental Venous Thromboembolism (VTE)

    Time frame: 3 months and 6 months

    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.

  4. New Deep Vein Thrombosis (DVT)

    Time frame: 3 months and 6 months

    New/recurrent any distal upper or lower extremity DVT or subsegmental PE.

  5. Superficial vein thrombosis of upper or lower extremities

    Time frame: 3 months and 6 months

    Superficial vein thrombosis of upper or lower extremities

  6. New unusual site Venous Thromboembolism (VTE)

    Time frame: 3 months and 6 months

    New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis).

  7. Clinically Relevant Non-Major Bleeding (CRNMB) events

    Time frame: 3 months and 6 months

    CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events.

  8. Arterial thromboembolic events

    Time frame: 3 months and 6 months

    Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism.

  9. All-cause mortality

    Time frame: 3 months and 6 months

    All-cause mortality

  10. Correlative biomarkers

    Time frame: 6 months

    Correlative biomarkers at 6 months, while the exact list of correlative biomarkers is to be determined at the time of study completion, examples include D-dimer, P-selectin, prothrombin F1+F2, thrombin generation, etc.

  11. Health-related quality of life using the EuroQoL-5D-5L Questionnaire

    Time frame: 6 months

    Health-related quality of life using EuroQoL-5D-5L (5Dimension- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5L- severity levels) questionnaires on enrollment and at 6 months. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.

Study contacts

Contact information is provided by the study sponsor or research team.

Tzu-Fei Wang, MD, MPH

CONTACT

[email protected]

6137379988 ext. 73755

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

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

Acronym: STREAM-Line

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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