Thromboprophylaxis With Rivaroxaban In Patients With Malignancy and Central Venous Lines (TRIM-Line)

• ClinicalTrials.gov Identifier: NCT03506815
• Recruitment Status: Recruiting
• First Posted: April 24, 2018
• Last Update Posted: August 13, 2019
• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Queen Elizabeth II Health Sciences Centre; University of Alberta; Hamilton Health Sciences Corporation
• Information provided by (Responsible Party): Ottawa Hospital Research Institute

Study Description

Brief Summary:

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.

Design:

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• 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)
• Primary Purpose: Prevention
• 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
• Estimated Primary Completion Date: December 30, 2019
• Estimated Study Completion Date: April 1, 2020

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Pilot Feasibility Outcome- Enrolment [ Time Frame: 6 months ]
   Number of Participants recruited per centre per month

Secondary Outcome Measures :

1. Consent rate [ Time Frame: 6 months ]
   Proportion of approached patients who consent to enter study.
2. Loss to follow up [ Time Frame: 6 months ]
   During the 90 (+/-3) days of the trial
3. Adherence to Therapy [ Time Frame: 6 months ]
   Good adherence defined as 80% or greater study medication taken
4. Proportion of screened patients which meet eligibility criteria [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. CVC in place for >72 hours
2. Patient requires anticoagulation for other indication
3. Concomitant use of dual antiplatelet therapy
4. Prior VTE
5. Major bleeding event in the last 6 weeks
6. Patient on concomitant medication with known interaction with rivaroxaban (eg. CYP3A4 inhibitor)
7. Pregnancy (documentation of use of effective contraception if sexually active or negative B-Hcg required)
8. Known renal failure, based on Creatinine clearance <30 mL/min (Cockcroft-Gault) (in the previous 3 months)
9. Documented severe liver disease (eg. acute clinical hepatitis, chronic active hepatitis, cirrhosis or ALT >3ULN) ( in the previous 3 months)
10. Known thrombocytopenia < 50x 109/L (in the previous 3 months)
11. Allergy to rivaroxaban
12. Life expectancy <6 months

13. History of condition at increased bleeding risk including, but not limited to:

    1. Major surgical procedure or trauma within 30 days before the randomization visit
    2. Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
    3. History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
    4. Chronic hemorrhagic disorder
    5. Known intracranial neoplasm, arteriovenous malformation, or aneurysm
    6. Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg
14. Primary malignancy diagnosis of basal cell or squamous cell carcinoma of the skin or acute leukemia or myelodysplastic syndrome
15. Geographic inaccessibility
16. Refused or unable to obtain consent

Contacts and Locations

Contacts

Contact: Rick T Ikesaka, MD; 6139838867; rikesaka@mcmaster.ca

Contact: Marc Carrier, MD, MSc; 6137378899 ext 73668; mcarrier@toh.ca

Locations

Canada, Ontario

The Ottawa Hospital General Campus; Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Ottawa Hospital Research Institute

Queen Elizabeth II Health Sciences Centre

University of Alberta

Hamilton Health Sciences Corporation

Investigators

• Principal Investigator: Rick T Ikesaka, MD; Ottawa Hospital Research Institute / Division of Hematology- The Ottawa Hospital

More Information

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03506815 History of Changes
• Other Study ID Numbers: 001
• First Posted: April 24, 2018
• Last Update Posted: August 13, 2019
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Pilot Feasibility Study- no current plan to share IPD

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ottawa Hospital Research Institute:

Upper Extremity Deep Vein Thrombosis; Thromboprophylaxis; Cancer; Randomized Trial

Additional relevant MeSH terms:

Thrombosis; Venous Thrombosis; Upper Extremity Deep Vein Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants