Recruiting

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

Apixaban

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

May, 2025

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:

1. 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.
2. 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.
3. Able and willing to provide informed consent.

Exclusion Criteria:

1. Active bleeding or other reasons for which anticoagulation is contraindicated.
2. Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
3. 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 .
4. Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy.
5. Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.

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

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 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 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

Tania Salvi

tsalvi@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 30, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-05-30.