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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03266783




Registration number
NCT03266783
Ethics application status
Date submitted
10/08/2017
Date registered
30/08/2017

Titles & IDs
Public title
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
Scientific title
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism
Secondary ID [1] 0 0
COBRRA
Universal Trial Number (UTN)
Trial acronym
COBRRA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Rivaroxaban

Active comparator: Apixaban group - 10 mg orally (PO), twice a day (BID) for 1 week, then 5 mg PO BID for 3 months of treatment

Active comparator: Rivaroxaban group - 15 mg orally (PO), twice a day (BID) for 3 weeks, then 20 mg PO once a day (OD) for 3 months of treatment


Treatment: Drugs: Apixaban
Refer to Apixaban group

Treatment: Drugs: Rivaroxaban
Refer to Rivaroxaban group
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The rate of adjudicated clinically relevant bleeding (CRB) events
Timepoint [1] 0 0
For the duration of the study: 3 months
Secondary outcome [1] 0 0
Adjudicated Major Bleeding events
Timepoint [1] 0 0
For the duration of the study: 3 months
Secondary outcome [2] 0 0
Adjudicated Clinically Relevant Non-Major Bleeding events
Timepoint [2] 0 0
For the duration of the study: 3 months
Secondary outcome [3] 0 0
Adjudicated recurrent VTE events
Timepoint [3] 0 0
For the duration of the study: 3 months
Secondary outcome [4] 0 0
Adjudicated VTE-related deaths
Timepoint [4] 0 0
For the duration of the study: 3 months
Secondary outcome [5] 0 0
All-cause mortality
Timepoint [5] 0 0
For the duration of the study: 3 months
Secondary outcome [6] 0 0
Medication adherence
Timepoint [6] 0 0
For the duration of the study: 3 months
Secondary outcome [7] 0 0
Quality-adjusted life years (QALYs) gained
Timepoint [7] 0 0
For the duration of the study: 3 months
Secondary outcome [8] 0 0
Incremental cost-effectiveness ratio
Timepoint [8] 0 0
For the duration of the study: 3 months
Secondary outcome [9] 0 0
Impact of verbal consent on patient participation in comparison with participants from sites using written informed consent
Timepoint [9] 0 0
For the duration of the study: 3 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
2760
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The University of Sydney - Darlington
Recruitment postcode(s) [1] 0 0
200606 - Darlington
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Ireland
State/province [6] 0 0
Dublin

Funding & Sponsors
Primary sponsor type
Other
Name
Ottawa Hospital Research Institute
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lana Castellucci, MD, FRCPC
Address 0 0
Ottawa Hospital Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lana Castellucci, MD, FRCPC
Address 0 0
Country 0 0
Phone 0 0
613-737-8899
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03266783