BridgeMD
New treatment option for Venous Thromboembolism
Official title Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters
ClinicalTrials.gov ID: NCT05029063
What this study is testing
What is Rivaroxaban 10 MG?
Rivaroxaban 10 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for venous thromboembolism.
Also referred to as Placebo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
You likely can't join if
- 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...
- Known pregnancy or plan to become pregnant in next 3 months
See the full eligibility criteria
- Patients 18 years of age or older with a new or existing diagnosis of cancer and a CVC inserted in the last 72 hours.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
- Brampton, Ontario, Canada
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Sault Ste. Marie, Ontario, Canada
- St. Catharines, Ontario, Canada
- Windsor, Ontario, Canada
- Greenfield Park, Quebec, Canada
- Lévis, Quebec, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada; Brampton, Ontario, Canada; Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Sault Ste. Marie, Ontario, Canada; St. Catharines, Ontario, Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.