Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (TRIM-Line)
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|ClinicalTrials.gov Identifier: NCT03506815|
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : July 23, 2020
Purpose of 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.
This is a pilot interventional study to be conducted at 3 Canadian Centres. The Ottawa Hospital, QEII Health Science Centre and University of Alberta Hospital.
It is an open label randomized controlled trial.
Consenting participants, meeting eligibility criteria will be randomized at the time of enrollment to one of two groups.
Rivaroxaban 10mg po daily x 90 (+/- 3 ) days OR Standard of Care
Participants in the treatment arm will have study drug dispensed at Day 1 and take medication for 90 days. Follow up visits (in person or phone) will occur at Day 30 (+/- 3 days) and Day 90 (+/- 3 days) month and 3 months post enrollment. Overall, participants will be followed for 3 months. Adverse events will be collected for the first 90 days.
Outcomes The primary feasibility outcome for the pilot study is the number of participants recruited per centre per month. We will obtain baseline details of the patient's type, location and treatment of cancer, comorbidities and medications. Secondary feasibility outcomes of the pilot study will include, consent rates, loss to follow up, adherence to therapy defining 80% or greater medication taken as having good adherence to study drug, proportion of screened patients who meet eligibility criteria.
|Condition or disease||Intervention/treatment||Phase|
|Upper Extremity Deep Vein Thrombosis Central Venous Catheter Thrombosis Cancer||Drug: Rivaroxaban 10 MG||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Pilot Trial comparing two groups - Rivaroxaban 10mg po daily x90 days vs standard of care(usual treatment)|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters|
|Actual Study Start Date :||March 15, 2019|
|Actual Primary Completion Date :||May 14, 2020|
|Actual Study Completion Date :||June 14, 2020|
Experimental: Rivaroxaban Thromboprophylaxis
Rivaroxaban 10 mg po daily for 90 days(+/- 3 days). After the Day - 90 follow up, the study treatment will be discontinued and subsequent treatment will be at the discretion of the attending physician.
Drug: Rivaroxaban 10 MG
Rivaroxaban 10mg po daily x 90 (+/- 3 days)
Other Name: Xarelto 10mg tablet po daily
No Intervention: Standard of care
No rivaroxaban prophylaxis. Management will be at the discretion of the attending physician.
- Pilot Feasibility Outcome- Enrolment [ Time Frame: 6 months ]Number of Participants recruited per centre per month
- Consent rate [ Time Frame: 6 months ]Proportion of approached patients who consent to enter study.
- Loss to follow up [ Time Frame: 6 months ]During the 90 (+/-3) days of the trial
- Adherence to Therapy [ Time Frame: 6 months ]Good adherence defined as 80% or greater study medication taken
- Proportion of screened patients which meet eligibility criteria [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506815
|The Ottawa Hospital General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Rick T Ikesaka, MD||Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital|