Venous Thromboembolism Clinical Trial
— COBRRAOfficial title:
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
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.
Status | Recruiting |
Enrollment | 2760 |
Est. completion date | December 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Australia | The University of Sydney | Darlington | New South Wales |
Canada | University of Calgary | Calgary | Alberta |
Canada | Alberta Health Sciences | Edmonton | Alberta |
Canada | QEII Health Science Centre | Halifax | Nova Scotia |
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 |
Canada | Hôpital Sacré-Coeur de Montréal | Montreal | Quebec |
Canada | St. Mary's Hospital | Montreal | Quebec |
Canada | Jewish General Hospital | Montréal | Quebec |
Canada | McGill University Health Center | Montréal | Quebec |
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Canada | CHU de Québec-Université Laval | Quebec city | Quebec |
Canada | University of Sherbrooke | Sherbrooke | Quebec |
Canada | UHN - Toronto General Hospital | Toronto | Ontario |
Canada | St. Paul's Hospital | Vancouver | British Columbia |
Ireland | The Royal College of Surgeons in Ireland/Mater Misericordiae University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | Canadian Institutes of Health Research (CIHR), Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network |
Australia, Canada, Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Adjudicated Major Bleeding events | For the duration of the study: 3 months | ||
Secondary | Adjudicated Clinically Relevant Non-Major Bleeding events | For the duration of the study: 3 months | ||
Secondary | Adjudicated recurrent VTE events | For the duration of the study: 3 months | ||
Secondary | Adjudicated VTE-related deaths | For the duration of the study: 3 months | ||
Secondary | All-cause mortality | For the duration of the study: 3 months | ||
Secondary | Medication adherence | For the duration of the study: 3 months | ||
Secondary | Quality-adjusted life years (QALYs) gained | For the duration of the study: 3 months | ||
Secondary | Incremental cost-effectiveness ratio | For the duration of the study: 3 months | ||
Secondary | Impact of verbal consent on patient participation in comparison with participants from sites using written informed consent | For the duration of the study: 3 months |
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