Venous ThromboembolismNCT02833987
Direct Oral Anticoagulants and Venous Thromboembolism
An observational study of Venous Thromboembolism and Major Bleed, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs) is associated with an increased risk of major bleeding compared to warfarin use, for the treatment of venous thromboembolism (VTE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Major Bleed
- What is being tested?
- Apixaban (ATC B01AF02), Dabigatran (ATC B01AE07) and Rivaroxaban (ATC B01AF01)
- How many people
- 59,525 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In each jurisdiction, the investigators will assemble a study cohort that includes all patients aged 18 years or older with a new prescription for a DOAC or warfarin between January 1, 2009 and 180 days prior to the end date of data availability within that jurisdiction and with an incident diagnosis of VTE within 30 days prior to the date of the cohort entry prescription.
Who may be able to join
- Patients with a new prescription for a DOAC or warfarin that had an incident diagnosis of VTE within the 30 days prior to the date of the prescription
- Patients at least 18 years of age (except Nova Scotia, Ontario, and Alberta, where patients will be at least 66 years of age)
- Patients with at least 1 year of history in the database
Who cannot join
- Patients with a diagnosis of VTE or atrial fibrillation ≤335 days prior to the incident VTE diagnosis
- Patients that received a prescription for a DOAC or warfarin within 1 year prior to the date of the cohort entry
- Patients who received prescriptions for both a DOAC and warfarin on the date of cohort entry
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparative Safety of Direct Oral Anticoagulants Versus Warfarin for the Treatment of Venous Thromboembolism
The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs) is associated with an increased risk of major bleeding compared to warfarin use, for the treatment of venous thromboembolism (VTE).
The investigators will carry out separate population based cohort studies using health administrative databases in eight jurisdictions in Canada, the UK and the US. Cohorts will be defined by the initiation of a DOAC or warfarin on or after January 1, 2009, with an incident diagnosis of VTE having occurred within 30 days prior to the date of the prescription for the DOAC or warfarin. Follow-up will continue until a hospitalization or emergency department visit for a major bleed. The results from separate sites will be combined to provide an overall assessment of the risk of major bleeding in DOAC users.
Read the detailed description
The objective of this study is to determine whether the use of direct oral anticoagulants (DOACs) is associated with an increased risk of major bleeding compared to warfarin use, for the treatment of venous thromboembolism (VTE).
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from eight jurisdictions (the Canadian provinces of Alberta, Manitoba, Nova Scotia, Ontario, Quebec, Saskatchewan, as well as the United Kingdon (UK) Clinical Practice Research Datalink and the United States (US) Marketscan). Briefly, the Canadian databases include population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs. The data in Nova Scotia, Ontario, and Alberta will be restricted to patients aged 65 years and older, as prescription data are not available for younger patients. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK.
In each jurisdiction, the investigators will assemble a study cohort that includes all patients newly prescribed a DOAC or warfarin from January 1, 2009 (or the earliest date of data availability at each site) to October 2, 2014 (or 180 days before the last date of data availability at each site, if earlier), that had an incident diagnosis of VTE within the 30 days prior to the date of the prescription. The date of study cohort entry will be defined by the prescription (for CPRD) or dispensation (for all other sites) date of the newly prescribed DOAC or warfarin. Patients in the study cohort will be followed from the date of study cohort entry until an event (defined below), censoring due to death or departure from the database, 3 months after cohort entry, or the end of the study period (March 31, 2015), whichever occurs first.
Exposure to a DOAC will be defined as a new prescription for a DOAC on the date of cohort entry. Exposure to warfarin will be defined as a new prescription for warfarin on the date of cohort entry. The investigators will use an analysis analogous to an intention-to-treat approach. The primary outcome will be defined as a hospitalization or emergency department visit for a major bleed within 3 months of cohort entry.
The study cohort will be analyzed using a matched cohort design, where up to 5 warfarin users will be matched to each DOAC user on sex, age, cohort entry date, and propensity score (which will be constructed using a multivariable logistic regression model estimating the odds of being treated with DOACs, while adjusting for a number of pre-identified covariates to account for baseline difference at the time of cohort entry). The hazard of major bleeding with DOAC use vs. warfarin use will be estimated using Cox-proportional hazards regression models accounting for the potential correlation in the matched pairs. Meta-analyses of the site-specific results will then be performed using fixed or random effects models (according to results of Chi-squared tests for heterogeneity). Sensitivity analyses will be conducted, all defined a priori, to assess the robustness of the results.
As secondary analyses, the investigators will: 1) assess the risk of all-cause mortality associated with DOAC use compared to warfarin use in the 3 months after cohort entry; 2) assess the risk of major bleeding associated with DOAC use compared to warfarin use, according to chronic kidney disease status; 3) determine (descriptively) the proportion of patients who experienced a major bleeding event by major bleed type; and 4) stratify the primary analysis by age (less than 66, 66-75, 76-85 and greater than 85), sex, and use of an anti-platelet medication in the 90 day period prior to cohort entry.
- Conditions
- Venous Thromboembolism, Major Bleed
- Being tested
- Apixaban (ATC B01AF02), Dabigatran (ATC B01AE07), Rivaroxaban (ATC B01AF01), Warfarin (ATC B01AA03)
- Keywords
- Direct oral anticoagulants, Safety, Major bleed, Adverse events
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban (ATC B01AF02)Drug
Exposure to apixaban (ATC B01AF02) will be defined as a new prescription for apixaban in the 30 days following the date of an incident VTE diagnosis.
Dabigatran (ATC B01AE07)Drug
Exposure to dabigatran (ATC B01AE07) will be defined as a new prescription for dabigatran in the 30 days following the date of an incident VTE diagnosis.
Rivaroxaban (ATC B01AF01)Drug
Exposure to rivaroxaban (ATC B01AF01) will be defined as a new prescription for rivaroxaban in the 30 days following the date of an incident VTE diagnosis.
Warfarin (ATC B01AA03)Drug
Exposure to warfarin (ATC B01AA03) will be defined as a new prescription for warfarin in the 30 days following the date of an incident VTE diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Treated with direct oral anticoagulants (DOACs) | Patients who received a new prescription for a DOAC (apixaban, dabigatran, or rivaroxaban) in the 30 days following the date of an incident VTE diagnosis, and did not have a previous prescription for a DOAC or warfarin in the year prior to the date of the new prescription. Receives: Drug: Apixaban (ATC B01AF02); Drug: Dabigatran (ATC B01AE07); Drug: Rivaroxaban (ATC B01AF01) | |
| Treated with warfarin | Patients who received a new prescription for warfarin in the 30 days following the date of an incident VTE diagnosis, and did not have a previous prescription for a DOAC or warfarin in the year prior to the date of the new prescription. Receives: Drug: Warfarin (ATC B01AA03) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleed
Patients hospitalized or visiting the emergency department for a major bleed recorded as the most responsible diagnosis in either the discharge abstract or hospitalization record with the following ICD codes:
ICD-9 codes: 430, 431, 432.0, 432.1, 432.9, 531.0, 531.2, 531.4, 531.6, 532.0, 532.2, 532.4, 532.6, 533.0, 533.2, 533.4, 533.6, 534.0, 534.2, 534.4, 534.6, 578.0, 578.1, 578.9, 569.3, 578.1, 578.9
ICD-10 codes: I60, I61, I62.0, I62.1, I62.9, K92.0, K92.1, I85.0, I98.20, I98.3, K22.10, K22.12, K22.14, K22.16, K25.0, K25.2, K25.4, K25.6, K26.0, K26.2, K26.4, K26.6, K27.0, K27.2, K27.4, K27.6, K28.0, K28.2, K28.4, K28.6, K29.0, K63.80, K31.80, K55.20, K62.5, K92.2, N02.0, N02.1, N02.2, N02.3, N02.4, N02.5, N02.6, N02.7, N02.8, N02.9, K66.1, N93.8, N93.9, N95.0, R04.1, R04.2, R04.8, R04.9, R31.0, R31.1, R31.8, R58, D68.3, H35.6, H43.1, H45.0, M25.0
Measured: Patients will be followed from the date of the first DOAC or warfarin prescription (study cohort entry) to a hospitalization or emergency department visit for a major bleed, censoring, or for up to 3 months, whichever occurred first.
Secondary outcomes (1)
All-cause mortality
Measured: Patients were followed from the date of the first DOAC or warfarin prescription (study cohort entry) until death, censoring or for up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 59,525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODES
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Brenda Hemmelgarn, MD, PhD, Principal investigator, Department of Community Health Sciences, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833987
- Sponsor's protocol ID
- Q14-02
- Status last verified
- Jan 2018
- First submitted
- 11 Jul 2016
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jun M, Lix LM, Durand M, Dahl M, Paterson JM, Dormuth CR, Ernst P, Yao S, Renoux C, Tamim H, Wu C, Mahmud SM, Hemmelgarn BR; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study. BMJ. 2017 Oct 17;359:j4323. doi: 10.1136/bmj.j4323.
PubMed 29042362
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Safety of Direct Oral Anticoagulants Versus Warfarin for the Treatment of Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT02833987
- Acronym / sponsor ID
- Q14-02
- Conditions
- Venous Thromboembolism, Major Bleed
- Keywords
- Direct oral anticoagulants, Safety, Major bleed, Adverse events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59,525 participants (actual)
- Lead sponsor
- Canadian Network for Observational Drug Effect Studies, CNODESUniversity, hospital or other
- Collaborators
- Drug Safety and Effectiveness Network, Canada, Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether use of direct oral anticoagulants (DOACs) is associated with an increased risk of major bleeding compared to warfarin use, for the treatment of venous thromboembolism (VTE).
The investigators will carry out separate population based cohort studies using health administrative databases in eight jurisdictions in Canada, the UK and the US. Cohorts will be defined by the initiation of a DOAC or warfarin on or after January 1, 2009, with an incident diagnosis of VTE having occurred within 30 days prior to the date of the prescription for the DOAC or warfarin. Follow-up will continue until a hospitalization or emergency department visit for a major bleed. The results from separate sites will be combined to provide an overall assessment of the risk of major bleeding in DOAC users.
Detailed description
The objective of this study is to determine whether the use of direct oral anticoagulants (DOACs) is associated with an increased risk of major bleeding compared to warfarin use, for the treatment of venous thromboembolism (VTE).
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from eight jurisdictions (the Canadian provinces of Alberta, Manitoba, Nova Scotia, Ontario, Quebec, Saskatchewan, as well as the United Kingdon (UK) Clinical Practice Research Datalink and the United States (US) Marketscan). Briefly, the Canadian databases include population-level data on physician billing, diagnoses and procedures from hospital discharge abstracts, and dispensations for prescription drugs. The data in Nova Scotia, Ontario, and Alberta will be restricted to patients aged 65 years and older, as prescription data are not available for younger patients. The CPRD is a clinical database that is representative of the UK population and contains the records for patients seen at over 680 general practitioner practices in the UK.
In each jurisdiction, the investigators will assemble a study cohort that includes all patients newly prescribed a DOAC or warfarin from January 1, 2009 (or the earliest date of data availability at each site) to October 2, 2014 (or 180 days before the last date of data availability at each site, if earlier), that had an incident diagnosis of VTE within the 30 days prior to the date of the prescription. The date of study cohort entry will be defined by the prescription (for CPRD) or dispensation (for all other sites) date of the newly prescribed DOAC or warfarin. Patients in the study cohort will be followed from the date of study cohort entry until an event (defined below), censoring due to death or departure from the database, 3 months after cohort entry, or the end of the study period (March 31, 2015), whichever occurs first.
Exposure to a DOAC will be defined as a new prescription for a DOAC on the date of cohort entry. Exposure to warfarin will be defined as a new prescription for warfarin on the date of cohort entry. The investigators will use an analysis analogous to an intention-to-treat approach. The primary outcome will be defined as a hospitalization or emergency department visit for a major bleed within 3 months of cohort entry.
The study cohort will be analyzed using a matched cohort design, where up to 5 warfarin users will be matched to each DOAC user on sex, age, cohort entry date, and propensity score (which will be constructed using a multivariable logistic regression model estimating the odds of being treated with DOACs, while adjusting for a number of pre-identified covariates to account for baseline difference at the time of cohort entry). The hazard of major bleeding with DOAC use vs. warfarin use will be estimated using Cox-proportional hazards regression models accounting for the potential correlation in the matched pairs. Meta-analyses of the site-specific results will then be performed using fixed or random effects models (according to results of Chi-squared tests for heterogeneity). Sensitivity analyses will be conducted, all defined a priori, to assess the robustness of the results.
As secondary analyses, the investigators will: 1) assess the risk of all-cause mortality associated with DOAC use compared to warfarin use in the 3 months after cohort entry; 2) assess the risk of major bleeding associated with DOAC use compared to warfarin use, according to chronic kidney disease status; 3) determine (descriptively) the proportion of patients who experienced a major bleeding event by major bleed type; and 4) stratify the primary analysis by age (less than 66, 66-75, 76-85 and greater than 85), sex, and use of an anti-platelet medication in the 90 day period prior to cohort entry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated with direct oral anticoagulants (DOACs) | – | Drug: Apixaban (ATC B01AF02), Drug: Dabigatran (ATC B01AE07), Drug: Rivaroxaban (ATC B01AF01)Patients who received a new prescription for a DOAC (apixaban, dabigatran, or rivaroxaban) in the 30 days following the date of an incident VTE diagnosis, and did not have a previous prescription for a DOAC or warfarin in the year prior to the date of the new prescription. |
| Treated with warfarin | – | Drug: Warfarin (ATC B01AA03)Patients who received a new prescription for warfarin in the 30 days following the date of an incident VTE diagnosis, and did not have a previous prescription for a DOAC or warfarin in the year prior to the date of the new prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In each jurisdiction, the investigators will assemble a study cohort that includes all patients aged 18 years or older with a new prescription for a DOAC or warfarin between January 1, 2009 and 180 days prior to the end date of data availability within that jurisdiction and with an incident diagnosis of VTE within 30 days prior to the date of the cohort entry prescription.
Key inclusion criteria (3 listed)
- Patients with a new prescription for a DOAC or warfarin that had an incident diagnosis of VTE within the 30 days prior to the date of the prescription
- Patients at least 18 years of age (except Nova Scotia, Ontario, and Alberta, where patients will be at least 66 years of age)
- Patients with at least 1 year of history in the database
Key exclusion criteria (3 listed)
- Patients with a diagnosis of VTE or atrial fibrillation ≤335 days prior to the incident VTE diagnosis
- Patients that received a prescription for a DOAC or warfarin within 1 year prior to the date of the cohort entry
- Patients who received prescriptions for both a DOAC and warfarin on the date of cohort entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apixaban (ATC B01AF02)Exposure to apixaban (ATC B01AF02) will be defined as a new prescription for apixaban in the 30 days following the date of an incident VTE diagnosis. | Drug | Treated with direct oral anticoagulants (DOACs) |
| Dabigatran (ATC B01AE07)Exposure to dabigatran (ATC B01AE07) will be defined as a new prescription for dabigatran in the 30 days following the date of an incident VTE diagnosis. | Drug | Treated with direct oral anticoagulants (DOACs) |
| Rivaroxaban (ATC B01AF01)Exposure to rivaroxaban (ATC B01AF01) will be defined as a new prescription for rivaroxaban in the 30 days following the date of an incident VTE diagnosis. | Drug | Treated with direct oral anticoagulants (DOACs) |
| Warfarin (ATC B01AA03)Exposure to warfarin (ATC B01AA03) will be defined as a new prescription for warfarin in the 30 days following the date of an incident VTE diagnosis. | Drug | Treated with warfarin |
Primary outcome
Major bleed
Time frame: Patients will be followed from the date of the first DOAC or warfarin prescription (study cohort entry) to a hospitalization or emergency department visit for a major bleed, censoring, or for up to 3 months, whichever occurred first.
Patients hospitalized or visiting the emergency department for a major bleed recorded as the most responsible diagnosis in either the discharge abstract or hospitalization record with the following ICD codes: ICD-9 codes: 430, 431, 432.0, 432.1, 432.9, 531.0, 531.2, 531.4, 531.6, 532.0, 532.2, 532.4, 532.6, 533.0, 533.2, 533.4, 533.6, 534.0, 534.2, 534.4, 534.6, 578.0, 578.1, 578.9, 569.3, 578.1, 578.9 ICD-10 codes: I60, I61, I62.0, I62.1, I62.9, K92.0, K92.1, I85.0, I98.20, I98.3, K22.10, K22.12, K22.14, K22.16, K25.0, K25.2, K25.4, K25.6, K26.0, K26.2, K26.4, K26.6, K27.0, K27.2, K27.4, K27.6, K28.0, K28.2, K28.4, K28.6, K29.0, K63.80, K31.80, K55.20, K62.5, K92.2, N02.0, N02.1, N02.2, N02.3, N02.4, N02.5, N02.6, N02.7, N02.8, N02.9, K66.1, N93.8, N93.9, N95.0, R04.1, R04.2, R04.8, R04.9, R31.0, R31.1, R31.8, R58, D68.3, H35.6, H43.1, H45.0, M25.0
1 secondary outcome
All-cause mortality
Time frame: Patients were followed from the date of the first DOAC or warfarin prescription (study cohort entry) until death, censoring or for up to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Results publication: PubMed 29042362Jun M, Lix LM, Durand M, Dahl M, Paterson JM, Dormuth CR, Ernst P, Yao S, Renoux C, Tamim H, Wu C, Mahmud SM, Hemmelgarn BR; Canadian Network for Observational Drug Effect Studies (CNODES) Investigators. Comparative safety of direct oral anticoagulants and warfarin in venous thromboembolism: multicentre, population based, observational study. BMJ. 2017 Oct 17;359:j4323. doi: 10.1136/bmj.j4323.
- This organization's website describing general functions, other CNODES projects, and investigator profiles.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Hemmelgarn, MD, PhD principal investigator
Department of Community Health Sciences, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Major Bleed, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleed (time frame: Patients will be followed from the date of the first DOAC or warfarin prescription (study cohort entry) to a hospitalization or emergency department visit for a major bleed, censoring, or for up to 3 months, whichever occurred first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.