CompletedPhase 4

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban: The Pilot Study

Canada72 participantsStarted 2016-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed newly diagnosed acute VTE (proximal lower extremity deep vein thrombosis and segmental or greater pulmonary embolism) * Age ≥ 18 years old * Written informed consent Exclusion Criteria: * Any contraindication for anticoagulation such as active bleeding * Clinically significant liver disease or alanine aminotransferase (ALT) levels ≥ 3 times the upper limit of normal range * Creatinine clearance \< 30 ml/min calculated with the Cockcroft-Gault formula (29) * Known allergies to either apixaban or rivaroxaban * Pregnancy * Use of contraindicated medications with apixaban or rivaroxaban * Active malignancy in the last 6 months (excluding localized skin malignancy) * No private insurance coverage for the study drug or not willing to pay for study drug

What they're measuring

Proportion of patients screened who are eligible to participate in the trial

Timeframe: For the duration of the study 3-6 months

Proportion of eligible patients who consent to participate in the trial

Timeframe: For the duration of the study 3-6 months

Proportion of patients who attend each follow-up visit

Timeframe: For the duration of the study 3-6 months

Proportion of patients completing all required study procedures, per follow-up visit

Timeframe: For the duration of the study 3-6 months

Trial details

NCT IDNCT02559856

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11

View on ClinicalTrials.gov More Venous Thromboembolism trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of patients screened who are eligible to participate in the trial

Timeframe: For the duration of the study 3-6 months

Proportion of eligible patients who consent to participate in the trial

Timeframe: For the duration of the study 3-6 months

Proportion of patients who attend each follow-up visit

Timeframe: For the duration of the study 3-6 months

Proportion of patients completing all required study procedures, per follow-up visit

Timeframe: For the duration of the study 3-6 months