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

NCT06603870 | Recruiting Phase 4 DMC

• 1 other identifier: STREAM-Line
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Venous Thromboembolism; Cancer; Upper Extremity Deep Vein Thrombosis; Catheter-Related Infections

Outcome Measures

Primary Outcomes (1)

• Venous Thromboembolism (VTE) Rate

  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.

  6 months

Secondary Outcomes (11)

• Major Venous Thromboembolism (VTE) and Major bleeding Rate

  3 months

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

  3 months and 6 months

• New incidental Venous Thromboembolism (VTE)

  3 months and 6 months

• New Deep Vein Thrombosis (DVT)

  3 months and 6 months

• Superficial vein thrombosis of upper or lower extremities

  3 months and 6 months

Study Arms (1)

Apixaban

EXPERIMENTAL

2.5 mg twice daily

Drug: Apixaban

Interventions

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.

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Neoplasms; Upper Extremity Deep Vein Thrombosis; Catheter-Related Infections

Interventions

apixaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Thrombosis; Thrombosis; Infections

Study Officials

• Tzu-Fei Wang, MD, MPH

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Fei Wang, MD, MPH

CONTACT

6137379988; tzwang@toh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Apixaban 2.5 mg twice daily

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: September 19, 2024
• Study Start: December 19, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)