Recruiting
Phase 4

VTE Management

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06603870

Conditions

Venous Thromboembolism

Cancer

Upper Extremity Deep Vein Thrombosis

Catheter-Related Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anticoagulation Therapy

Study Details

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

Study ID

NCT06603870

Start date

Dec 19, 2024

Status verified date

Sep, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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.

Study Design

Enrollment

330 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Apixaban

2.5 mg twice daily

Interventions

Anticoagulation Therapy

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.

Primary outcome measure

  • Venous Thromboembolism (VTE) Rate [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Tzu-Fei Wang, MD, MPH

6137379988tzwang@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Cecilia Germano

cegermano@ohri.ca

Sault Area Hospital

Recruiting

Sault Ste. Marie, Ontario, Canada

Contacts

Natalie Walde

walden@sah.on.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.