Comparison of Bleeding Risk Between Rivaroxaban and Apixaban

Venous Thromboembolism Clinical Trial

— COBRRA Pilot  

Official title:

Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism: The Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559856
• Other study ID #: COBRRA Pilot
• Secondary ID: 20150574-01H
• Status: Completed
• Phase: Phase 4
• Start date: May 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2024
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban

• Rivaroxaban

Locations

Country	Name	City	State
Canada	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

Sponsors (3)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients screened who are eligible to participate in the trial		For the duration of the study 3-6 months
Primary	Proportion of eligible patients who consent to participate in the trial		For the duration of the study 3-6 months
Primary	Proportion of patients who attend each follow-up visit		For the duration of the study 3-6 months
Primary	Proportion of patients completing all required study procedures, per follow-up visit		For the duration of the study 3-6 months
Secondary	Bleeding Events	Major bleeding events, clinically relevant non-major and minor bleeding episodes	For the duration of the study 3-6 months
Secondary	Venous Thromboembolism	Recurrent VTE and VTE related-death	For the duration of the study 3-6 months
Secondary	Death	All-cause mortality rates; Individual rates of death related to VTE, cardiovascular disease, bleeding or other causes	For the duration of the study 3-6 months
Secondary	Medication compliance as assessed by study pill count		For the duration of the study 3-6 months
Secondary	Time-to-event analysis	The time-to-first occurrence of secondary outcomes between randomization and end of follow-up	For the duration of the study 3-6 months