Apixaban for Blood Clots in Cancer Patients

(STREAM-Line Trial)

Overseen By Tzu-Fei Wang, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must be taking: Anticoagulants

Must not be taking: Strong enzyme inhibitors

Disqualifiers: Active bleeding, Atrial fibrillation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 90

330 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Tzu-Fei Wang, MD, MPH

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for cancer patients who have had a catheter-related blood clot in an upper extremity and completed 3 months of standard blood thinner treatment. Specific eligibility details are not provided, so it's best to contact the study team for more information.

Inclusion Criteria

Able and willing to provide informed consent

I am an adult with cancer diagnosed or treated in the last 6 months, not in complete remission.

I have had a blood clot in my arm due to a catheter and have been on blood thinners for at least 3 months.

Exclusion Criteria

I am not on blood thinners at the time of joining the study.

Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy

I do not have active bleeding or conditions that prevent blood thinning treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive standard therapeutic anticoagulation for 3 months

12 weeks

STREAM-Line Management

Participants are managed with a prophylactic dose of apixaban as long as a central venous catheter or active cancer is present

Up to 6 months

Day 90±14 and Day 180+14 follow-up visits by phone call or in person

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Apixaban

Trial Overview The trial is testing Apixaban as a secondary prevention strategy for deep vein thrombosis (DVT) after initial anticoagulation therapy in cancer patients with catheter-related DVT.

Participant Groups

Group I: Apixaban Experimental Treatment 1 Intervention

2.5 mg twice daily

Apixaban is already approved in European Union, United States for the following indications:

Approved in European Union as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation

Approved in United States as Eliquis for:

• Deep vein thrombosis
• Pulmonary embolism
• Nonvalvular atrial fibrillation
• Stroke prevention

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+