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: 2

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; Catheter-Related Infections; Upper Extremity Deep Vein Thrombosis

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: Anticoagulation Therapy

Interventions

Anticoagulation Therapy DRUG

Patients will be enrolled after at least 3 months of therapeutic anticoagulation for an acute catheter-related upper extremity DVT while they are treated with therapeutic anticoagulation as standard of care. After enrollment, patients will be managed with prophylactic dose of anticoagulation as long as either a CVC or active cancer is present. If cancer goes into remission, at the time of CVC removal, anticoagulation will be stopped, but patients will continue to be followed until the end of the study at 6 months.

Also known as: Apixaban

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 for \> 5 days prior to enrollment for any reasons.
• Pregnancy or breast feeding in patients who are prescribed a direct oral anticoagulant.
• Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 and P-glycoprotein in patients who are prescribed a direct oral anticoagulant.
• Cancer is in remission and CVC is removed prior to enrollment.
• Requirement of dual antiplatelet therapies.
• Platelet count \< 50 x 109/L or creatinine clearance \< 30 ml/min.
• Life expectancy of less than 3 months.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

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

Interventions

Anticoagulation Bridge; apixaban

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bridge Therapy; Therapeutics

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: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)