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Anticoagulant

Apixaban for Blood Clots in Cancer Patients (STREAM-Line Trial)

Phase 4
Waitlist Available
Led By Tzu-Fei Wang, MD, MPH
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients (≥ 18 years old) with active cancer diagnosed or treated within 6 months, presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission
Patients with objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation for at least 3 months
Must not have
Not on therapeutic anticoagulation at the time of enrollment
Active bleeding or other reasons for which anticoagulation is contraindicated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

"This trial aims to study a new treatment plan for patients with cancer and deep vein thrombosis in their arm veins after they have already been on standard blood thinning medication for 3 months."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Apixaban may cause bleeding complications, which can range from minor bruising to serious or potentially life-threatening bleeds. It might also cause allergic reactions or liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an adult with cancer diagnosed or treated in the last 6 months, not in complete remission.
Select...
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

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not on blood thinners at the time of joining the study.
Select...
I do not have active bleeding or conditions that prevent blood thinning treatments.
Select...
I need blood thinners for more than 3 months for another health issue.
Select...
I am not taking medication that strongly affects certain liver enzymes or drug transporters.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Venous Thromboembolism (VTE) Rate
Secondary study objectives
All-cause mortality
Arterial thromboembolic events
Clinically Relevant Non-Major Bleeding (CRNMB) events
+8 more

Side effects data

From 2018 Phase 4 trial • 557 Patients • NCT01884337
7%
Incision site pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
TOTAL KNEE REPLACEMENT (TKR)
TOTAL HIP REPLACEMENT (THR)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ApixabanExperimental Treatment1 Intervention
2.5 mg twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apixaban
2011
Completed Phase 4
~132290

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,094,553 Total Patients Enrolled
Tzu-Fei Wang, MD, MPHPrincipal InvestigatorOttawa Hospital Research Institute
~220 spots leftby Oct 2029
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