This vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood thinners for the treatment of blood clots. Half of the patients will receive apixaban and half will receive rivaroxaban. The main objective is to determine the feasibility of patient recruitment and resources required to follow enrolled patients and inform for a larger, multi-centered trial and to assess which one is safer.
Recently developed new oral anticoagulants (OAC) overcome some of the limitations of established therapy with vitamin K antagonists (VKA) and low molecular weight heparin (LMWH) for treatment of acute venous thromboembolism (VTE), due to ease of administration and more predictable pharmacokinetic properties. Many clinical questions about the new OAC remain unanswered because there have not been direct head-to-head comparison trials. For example, although studies have shown that rivaroxaban and apixaban are at least as effective and safe as LMWH and VKA, meta-analyses suggest that apixaban may be associated with lower bleeding risk. Concerns about the potential impact of medication non-adherence have been raised. Compliance with twice daily medications (e.g. apixaban) is often worse than once daily medications (e.g. rivaroxaban). Both of these medications are approved by Health Canada for treatment of VTE yet there is genuine uncertainty about which of the two direct OAC confer the best risk-to-benefit ratio.This is a multi-centre, prospective randomized open blinded end-point (PROBE) trial assessing clinical feasibility for a larger multi-centered trial comparing bleeding outcomes using apixaban vs. rivaroxaban for treatment of acute VTE. The primary objective of the study is to determine if it is feasible to conduct a large randomized multicenter trial comparing apixaban vs. rivaroxaban for the treatment of acute VTE. The secondary objectives are to assess safety and superiority of apixaban vs rivaroxaban.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
University of Alberta
Edmonton, Alberta, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Hôtel-Dieu de Sherbrooke
Sherbrooke, Quebec, Canada
Number of Patients Screened Who Are Eligible to Participate in the Trial
Assessing clinical feasibility for a larger multi-center trial - number of screened patients versus eligible patients
Time frame: For the duration of the study 3-6 months
Number of Eligible Patients Who Consent to Participate in the Trial
Assessing clinical feasibility for a larger multi-center trial - number of eligible patients versus patients who consent to participate
Time frame: For the duration of the study 3-6 months
Number of Patients Who Attend Each Follow-up Visit
Assessing clinical feasibility for a larger multi-center trial - number of patients that miss visits versus patients that attend visits.
Time frame: For the duration of the study 3-6 months
Number of Patients Completing All Required Study Procedures, Per Follow-up Visit
Assessing clinical feasibility for a larger multi-center trial - number of patients that complete all required procedures/study visits versus patients that do not.
Time frame: For the duration of the study, 3-6 months
Number of Participants With Major Bleeding, Clinically Relevant Non-Major, Minor Bleeding, or No Bleeding Events
Number of participants with major bleeding events, clinically relevant non-major bleed events (CRNMB), minor bleeding events, or no bleeding events
Time frame: For the duration of the study 3-6 months
Number of Participants With Recurrent VTE
Number of Participants with Recurrent Venous Thromboembolism (VTE)
Time frame: For the duration of the study 3-6 months
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Number of Participants With All-Cause Mortality
* All-cause mortality rates * Individual rates of death related to VTE, cardiovascular disease, bleeding or other causes
Time frame: For the duration of the study 3-6 months
Mean Percentage of Participant Medication Compliance
A participant's compliance to medication based of "dose-taking", which is defined by the percentage of the prescribed doses of pills actually taken by the patient over the study period. A dose-taking of less than 80% will be considered non-compliant. Dose-taking will be assessed by calculating the percentage of 1) study pill count (percentage will be achieved by reviewing the quantities of the medication prescribed and returned); 2) participant medication diary (participant will self-report dose-taking and missed doses); and 3) electronic prescription bottle cap (eCAP) (using a Medication Event Monitoring System (MEMS), which will record and imprint the time of opening the medication container on multiple occasions, which will be used to calculate doses taken vs. missed doses. This method of recording data on adherence will provide preliminary data about rates of non-compliance and will be compared to the conventional methods of self-reporting and pill count for efficacy and safety).
Time frame: For the duration of the study 3-6 months
Time-to-Event Analysis
The time-to-first occurrence of secondary outcomes between randomization and end of follow-up
Time frame: For the duration of the study 3-6 months