Phase 3
N=105
Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines
Upper Extremity Deep Vein Thrombosis · Central Venous Catheter Thrombosis · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03506815 ↗Enrolled (actual)
105
Serious AEs
20.0%
Results posted
Jul 2024
Primary outcome: Primary: Primary Feasibility Outcome - Number of Participants Recruited Per Month — 7.5; 2.0 Average enrolment rate/month/site
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban 10 MG (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Feasibility Outcome - Number of Participants Recruited Per Month |
7.5; 2.0 | — |
| SECONDARY Secondary Feasibility Outcomes - Percentage of Participants With Good Adherence to Therapy |
96.7 | — |
Summary
Purpose of the Pilot Trial:
To determine the feasibility of conducting a multicentre randomized open label controlled trial evaluating the use of prophylactic dose rivaroxaban to prevent central venous catheter (CVC) associated venous thromboembolism (VTE) among cancer patients.
Hypothesis: treatment with low dose rivaroxaban (10mg) will reduce the incidence of upper extremity venous thrombosis in a high risk population with cancer and CVC.
Eligibility Criteria
Inclusion Criteria
1.Patients 18 years of age or older with a new or existing diagnosis of cancer with a CVC inserted within the last 72 hours.
Exclusion Criteria
- CVC in place for >72 hours
- Patient requires anticoagulation for other indication
- Concomitant use of dual antiplatelet therapy
- Prior VTE
- Major bleeding event in the last 6 weeks
- Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
- Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
- Known renal failure, based on Creatinine clearance 3ULN) ( in the previous 3 months)
- Known thrombocytopenia < 50x 109/L (in the previous 3 months)
- Allergy to rivaroxaban
- Life expectancy <6 months
- History of condition at increased bleeding risk including, but not limited to:
- Major surgical procedure or trauma within 30 days before the randomization visit
- Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
- History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
- Chronic hemorrhagic disorder
- Known intracranial neoplasm, arteriovenous malformation, or aneurysm
- Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
- Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
- Geographic inaccessibility
- Refused or unable to obtain consent
Data sourced from ClinicalTrials.gov (NCT03506815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.