Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
COBRRA
1 other identifier
interventional
2,760
3 countries
19
Brief Summary
Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2017
Longer than P75 for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2025
CompletedNovember 17, 2025
November 1, 2025
7.4 years
August 10, 2017
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The rate of adjudicated clinically relevant bleeding (CRB) events
CRB events are defined as the composite of major bleeding (MB) events and clinically relevant non-major bleeding (CRNMB) events.
For the duration of the study: 3 months
Secondary Outcomes (9)
Adjudicated Major Bleeding events
For the duration of the study: 3 months
Adjudicated Clinically Relevant Non-Major Bleeding events
For the duration of the study: 3 months
Adjudicated recurrent VTE events
For the duration of the study: 3 months
Adjudicated VTE-related deaths
For the duration of the study: 3 months
All-cause mortality
For the duration of the study: 3 months
- +4 more secondary outcomes
Study Arms (2)
Apixaban group
ACTIVE COMPARATOR10 mg orally (PO), twice a day (BID) for 1 week, then 5 mg PO BID for 3 months of treatment
Rivaroxaban group
ACTIVE COMPARATOR15 mg orally (PO), twice a day (BID) for 3 weeks, then 20 mg PO once a day (OD) for 3 months of treatment
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed newly diagnosed symptomatic acute venous thromboembolism (VTE) \[proximal lower extremity deep vein thrombosis (DVT) or segmental or greater pulmonary embolism (PE)\]
- Age ≥ 18 years old
- Informed consent obtained
You may not qualify if:
- Have received \> 72 hours of therapeutic anticoagulation
- Creatinine clearance \< 30 ml/min calculated with the Cockcroft-Gault formula
- Any contraindication for anticoagulation with apixaban or rivaroxaban as determined by the treating physician such as, but not limited to:
- active bleeding,
- active malignancy, defined as a) diagnosed with cancer within the past 6 months; or b) recurrent, regionally advanced or metastatic disease; or c) currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or d) a hematologic malignancy not in complete remission,
- weight \> 120 kg,
- liver disease (Child-Pugh Class B or C),
- use of contraindicated medications
- another indication for long-term anticoagulation (e.g. atrial fibrillation)
- pregnant (note below) or breastfeeding (Note: as reported by the patient or a pregnancy test will be ordered at the discretion of the treating physician for women of childbearing potential as per standard of care)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
The University of Sydney
Darlington, New South Wales, 200606, Australia
University of Calgary
Calgary, Alberta, Canada
Alberta Health Sciences
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
QEII Health Science Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Center
London, Ontario, N6A 5W9, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6, Canada
UHN - Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
McGill University Health Center
Montreal, Quebec, H4A 3J1, Canada
Hôpital Sacré-Coeur de Montréal
Montreal, Quebec, Canada
St. Mary's Hospital
Montreal, Quebec, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
The Royal College of Surgeons in Ireland/Mater Misericordiae University Hospital
Dublin, Ireland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lana Castellucci, MD, FRCPC
Ottawa Hospital Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2017
First Posted
August 30, 2017
Study Start
December 13, 2017
Primary Completion
April 30, 2025
Study Completion
September 8, 2025
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share