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Venous ThromboembolismPhase 3TRIM-LineNCT05029063

Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters

A Phase 3 study testing Rivaroxaban 10 MG in people with Venous Thromboembolism and Cancer, run by Ottawa Hospital Research Institute at 11 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism, Cancer
What is being tested?
Rivaroxaban 10 MG
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,828 participants
Where
11 sitesCanada
Study dates
5 Oct 2022to Dec 2027
Phase
Phase 3
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

  • Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.

Who cannot join

  • CVC in place for >72 hours
  • Patient requires anticoagulation for other indications
  • Concomitant use of dual antiplatelet therapy
  • Major bleeding event in the last 4 weeks
  • Patients receiving concomitant systemic treatment with strong inhibitors of both CYP 3A4 and P-gp (such as cobicistat, ketoconazole, itraconazole, posaconazole, or ritonavir).
  • Known pregnancy or plan to become pregnant in next 3 months
Show all 16Show fewer
  • Severe renal insufficiency (Creatinine clearance <30 mL/min (defined by Cockcroft-Gault) in the previous 3 months
  • Documented severe liver disease (e.g., acute clinical hepatitis, chronic active hepatitis or cirrhosis) in the previous 3 months
  • Known thrombocytopenia (platelet count < 50x 109/L) in the previous 3 months
  • Known allergy to rivaroxaban
  • Life expectancy <3 months
  • History of condition at increased bleeding risk including, but not limited to:
  • cerebral infarction (hemorrhagic or ischemic), active peptic ulcer disease with recent bleeding, spontaneous or acquired impairment of hemostasis in the past 4 weeks.
  • Chronic hemorrhagic disorder
  • Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin only
  • Refused or unable to obtain consent

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bashour Yazji contact

613-737-8899 ext. 73958

byazji@ohri.ca

11 sites in 1 country

Canada11 sites, 11 recruiting

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

    Recruiting

  • CISSS Montérégie-Centre HOPITAL CHARLES LEMOYNE

    Greenfield Park, Quebec, J4V 2H1

    Recruiting

  • Nova Scotia Health

    Halifax, Nova Scotia

    Recruiting

  • HHS - Juravinski Hospital

    Hamilton, Ontario, L8V 1C3

    Recruiting

  • Centre Intégré de santé et de services sociaux de Chaudière-Appalaches

    Lévis, Quebec

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • McGill University Health Center

    Montreal, Quebec

    Recruiting

  • Ottawa Hospital Research Institute- The Ottawa Hospital

    Ottawa, Ontario, K1H8L6

    Amanda Pecarskie, 6137378899, apecarskie@ohri.ca

    Madeline Hill, 613-737-8899, madhill@ohri.ca

    Recruiting

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, 750 Great Northern Rd.

    Recruiting

  • Niagara Health

    St. Catharines, Ontario, L2S0A9

    Recruiting

  • Windsor Regional Hospital

    Windsor, Ontario, N8W 1L9

    Recruiting

Other trials in Canada

About this study

Official title: Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial

The purpose of the full trial is to determine the efficacy and safety of prophylactic dose rivaroxaban to prevent VTE among cancer patients with CVC.

Read the detailed description

TRIM-Line is a double blind randomized controlled trial comparing rivaroxaban 10mg po daily vs placebo in patients with active cancer and indwelling CVC. This will involve 9 centers across Canada.

Being tested
Rivaroxaban 10 MG
Medical subject headings
Venous Thromboembolism, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban 10 MGDrug

    Also called Placebo

    Identical comparator drug

Study groups in NCT05029063
Study groupRoleWhat they receive
ExperimentalExperimentalRivaroxaban 10mg OD
Receives: Drug: Rivaroxaban 10 MG
ControlPlacebo comparatorIdentical Placebo 10mg OD
Receives: Drug: Rivaroxaban 10 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major VTE prevention

    Number of Major VTE's in patient population

    Measured: 90 days (± 3 days) of randomization

  2. Episodes of Major Bleeding

    Number of participants who had a major bleed

    Measured: 90 days (± 3 days) of randomization

Secondary outcomes (17)

  1. Number of participants with Clinically Relevant Non-Major Bleeding (CRNMB)

    As defined by ISTH

    Measured: 90 days (± 3 days) of randomization

  2. Number of patients who had a fatal VTE

    Fatal VTE

    Measured: 90 days (± 3 days) of randomization

  3. Number of patients who benefitted from using the experimental intervention

    Composite of major VTE and major bleeding

    Measured: 90 days (± 3 days) of randomization

  4. PE

    Incidental and Symptomatic

    Measured: 90 days (± 3 days) of randomization

  5. Proximal CVC VTE

    Incidental and symptomatic proximal (axillary vein or more proximal) upper extremity CVC-related DVT

    Measured: 90 days (± 3 days) of randomization

  6. Distal CVC VTE

    Incidental and symptomatic distal (brachial vein) or proximal (axillary vein or more proximal) upper extremity CVC-related DVT

    Measured: 90 days (± 3 days) of randomization

  7. Proximal Lower extremity DVT

    Incidental and symptomatic proximal (popliteal vein or more proximal) lower extremity DVT

    Measured: 90 days (± 3 days) of randomization

  8. Distal Lower extremity DVT

    Incidental and symptomatic distal or proximal (popliteal vein or more proximal) lower extremity DVT

    Measured: 90 days (± 3 days) of randomization

  9. Number of participants with Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses

    Unusual site thrombosis including: splanchnic vein (portal, splenic, superior mesenteric, inferior mesenteric, hepatic) cerebral vein, renal or gonadal vein thromboses

    Measured: 90 days (± 3 days) of randomization

  10. Number of participants with Superficial upper or lower extremity vein thrombosis

    Superficial upper or lower extremity vein thrombosis

    Measured: 90 days (± 3 days) of randomization

  11. Number of participants with an arterial thromboembolic event including: MI, stroke, peripheral arterial disease

    Arterial thromboembolic events defined as a diagnostically confirmed final clinical diagnosis of myocardial infarction, stroke or peripheral arterial disease involving the following arterial vascular beds: carotid, upper or lower extremity, gastrointestinal tract, liver, spleen, or kidney

    Measured: 90 days (± 3 days) of randomization

  12. CVC Life-span

    Life span of inserted CVC

    Measured: 90 days (± 3 days) of randomization

  13. Number of patients with CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications.

    CVC occlusion occurring after the start of therapy, defined as an obstruction of the CVC lumen that prevents or limits the ability to flush, withdraw blood and/or administer solutions or medications.

    Measured: 90 days (± 3 days) of randomization

  14. Number of patients with CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention

    CVC-related blood stream infection defined as the presence of bacteremia originating from the CVC according to the definition from the Centers for Disease Control and Prevention

    Measured: 90 days (± 3 days) of randomization

  15. Number of participants who passed away during the trial

    Overall mortality

    Measured: 90 days (± 3 days) of randomization

  16. EQ-5D-5L Health-related quality of life

    Health-related quality of life

    Measured: 90 days (± 3 days) of randomization

  17. ICER

    Incremental cost-effectiveness ratio (ICER) at one year

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start5 Oct 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,828 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029063
Sponsor's protocol ID
TRIM-Line 3698
Acronym
TRIM-Line
Status last verified
Jul 2025
First submitted
30 Jun 2021
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ikesaka R, Siegal D, Mallick R, Wang TF, Witham D, Webb C, Carrier M; Canadian Venous Thromboembolism Research Network (CanVECTOR). Thromboprophylaxis with rivaroxaban in patients with malignancy and central venous lines (TRIM-Line): A two-center open-label pilot randomized controlled trial. Res Pract Thromb Haemost. 2021 May 5;5(4):e12517. doi: 10.1002/rth2.12517. eCollection 2021 May.

    PubMed 34027291

  • Wang TF, Ikesaka R, Mahe I, Hill D, Sperlich C, Tagalakis V, Shivakumar S, Leonard B, Cervi A, Kuruvilla P, Larose F, Matino D, Frosi Stella S, Seguin C, Al Raizah A, Le Gal G, Siegal DM, Delluc A, Mallick R, Lazo-Langner A, Wu C, Christopher D, Di Nisio M, Ageno W, Yazji B, Carrier M. Primary thromboprophylaxis in patients with malignancy and central venous catheters: TRIM-Line randomized controlled trial - Design and rationale. Thromb Haemost. 2026 Sep 21. doi: 10.1055/a-2963-4656. Online ahead of print.

    PubMed 42767263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban 10 MG in people with Venous Thromboembolism and Cancer, run by Ottawa Hospital Research Institute at 11 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 1 inclusion and 16 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Bashour Yazji (613-737-8899 ext. 73958, byazji@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major VTE prevention (time frame: 90 days (± 3 days) of randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05029063, which also lists 2 linked publications.

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 9 Jul 2025.

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