Venous ThromboembolismPhase 4STREAM-LineNCT06603870
Secondary Prevention of VTE in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis
A Phase 4 study testing Anticoagulation Therapy in people with Venous Thromboembolism and Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Cancer, Upper Extremity Deep Vein Thrombosis
- What is being tested?
- Anticoagulation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Dec 2024to Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Requirement of dual antiplatelet therapies.
- Platelet count < 50 x 109/L or creatinine clearance < 30 ml/min.
- Life expectancy of less than 3 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Cecilia Germano, cegermano@ohri.ca
- Recruiting
Sault Area Hospital
Sault Ste. Marie, Ontario
Natalie Walde, walden@sah.on.ca
About this study
Official title: Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)
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).
Read the detailed description
The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. 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 central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.
- Conditions
- Venous Thromboembolism, Cancer, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections
- Being tested
- Anticoagulation Therapy
- Medical subject headings
- Venous Thromboembolism, Neoplasms, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation TherapyDrug
Also called Apixaban
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.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Experimental | 2.5 mg twice daily Receives: Drug: Anticoagulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
Major Venous Thromboembolism (VTE) and Major bleeding Rate
Rates of new/recurrent symptomatic major VTE and major bleeding at 3 months.
Measured: 3 months
New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
New/recurrent symptomatic catheter-related upper extremity DVT.
Measured: 3 months and 6 months
New incidental Venous Thromboembolism (VTE)
New incidental VTE (PE or upper or lower extremity DVT), defined as VTE diagnosed on imaging studies obtained not for concern of VTE, such as cancer staging scans.
Measured: 3 months and 6 months
New Deep Vein Thrombosis (DVT)
New/recurrent any distal upper or lower extremity DVT or subsegmental PE.
Measured: 3 months and 6 months
Superficial vein thrombosis of upper or lower extremities
Superficial vein thrombosis of upper or lower extremities
Measured: 3 months and 6 months
New unusual site Venous Thromboembolism (VTE)
New unusual site VTE (such as splanchnic vein, cerebral vein, or gonadal vein thrombosis).
Measured: 3 months and 6 months
Clinically Relevant Non-Major Bleeding (CRNMB) events
CRNMB events by International Society on Thrombosis and Haemostasis (ISTH) criteria2 and composite major bleeding and CRNMB events.
Measured: 3 months and 6 months
Arterial thromboembolic events
Arterial thromboembolic events (objectively confirmed), including myocardial infarction, stroke, peripheral arterial disease, or other systemic arterial embolism.
Measured: 3 months and 6 months
All-cause mortality
All-cause mortality
Measured: 3 months and 6 months
Correlative biomarkers
Correlative biomarkers at 6 months, while the exact list of correlative biomarkers is to be determined at the time of study completion, examples include D-dimer, P-selectin, prothrombin F1+F2, thrombin generation, etc.
Measured: 6 months
Health-related quality of life using the EuroQoL-5D-5L Questionnaire
Health-related quality of life using EuroQoL-5D-5L (5Dimension- mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5L- severity levels) questionnaires on enrollment and at 6 months. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Dec 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Apixaban 2.5 mg twice daily
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzu-Fei Wang, MD, MPH, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603870
- Sponsor's protocol ID
- STREAM-Line
- Acronym
- STREAM-Line
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)
- ClinicalTrials.gov ID
- NCT06603870
- Acronym / sponsor ID
- STREAM-Line / STREAM-Line
- Conditions
- Venous Thromboembolism, Cancer, Upper Extremity Deep Vein Thrombosis, Catheter-Related Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. 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 central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Apixaban 2.5 mg twice daily
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Experimental | Drug: Anticoagulation Therapy2.5 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulation TherapyAlso: ApixabanPatients 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. | Drug | Apixaban |
Primary outcome
Venous Thromboembolism (VTE) Rate
Time frame: 6 months
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.
11 secondary outcomes
Major Venous Thromboembolism (VTE) and Major bleeding Rate
Time frame: 3 months
New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).
Time frame: 3 months and 6 months
New incidental Venous Thromboembolism (VTE)
Time frame: 3 months and 6 months
New Deep Vein Thrombosis (DVT)
Time frame: 3 months and 6 months
Superficial vein thrombosis of upper or lower extremities
Time frame: 3 months and 6 months
New unusual site Venous Thromboembolism (VTE)
Time frame: 3 months and 6 months
Clinically Relevant Non-Major Bleeding (CRNMB) events
Time frame: 3 months and 6 months
Arterial thromboembolic events
Time frame: 3 months and 6 months
All-cause mortality
Time frame: 3 months and 6 months
Correlative biomarkers
Time frame: 6 months
Health-related quality of life using the EuroQoL-5D-5L Questionnaire
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tzu-Fei Wang, MD, MPH principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anticoagulation Therapy in people with Venous Thromboembolism and Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Fei Wang, MD, MPH (6137379988 ext. 73755, tzwang@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Thromboembolism (VTE) Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.