Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs Warfarin) (NCT03596502) | Clinical Trial Compass
CompletedNot Applicable
Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs Warfarin)
Canada402,764 participantsStarted 2018-02-01
Plain-language summary
The purpose of this study is to assess safety and effectiveness of direct oral anticoagulants (DOACs) and warfarin for stroke prevention in patients with non-valvular atrial fibrillation (AF). The comparison of DOACs versus oral vitamin K antagonists, in particular warfarin, is of interest.
The investigators will carry out separate population-based, matched cohort studies, using health administrative databases in seven Canadian provinces. New users of oral anticoagulants (DOACs or warfarin) for stroke prevention in non-valvular AF will be eligible to enter the cohorts. Follow-up will continue until a hospitalization or emergency department visit for a stroke. The results from the separate sites will be combined by meta-analysis to provide an overall assessment of the safety and effectiveness of the different anticoagulation regimens in stroke prevention in AF.
The investigators hypothesize that DOACs and warfarin will have similar safety and effectiveness profiles.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a new prescription for an oral anticoagulant that had a diagnosis of atrial fibrillation or atrial flutter within the 3 years prior to the date of the prescription
* Patients aged 18 years or older (except Alberta, Nova Scotia, and Ontario, where patients will be aged at least 66 years or older)
Exclusion Criteria:
* Patients with less than one year of data availability prior to cohort entry
* Patients with a diagnosis of valvular disease (including rheumatic heart disease) or prior cardiac valve surgery
* Patients with a diagnosis of venous thromboembolic disease in the year prior to cohort entry
* Patients who underwent hemodialysis in the 90 days prior to cohort entry
* Patients with a hip, femur, or knee surgery in the 30 days prior to cohort entry
* Patients with a diagnosis of antiphospholipid syndrome
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ischemic stroke (IS) or systemic embolization (SE)
Timeframe: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until a hospitalization or ED visit for IS or SE, censoring due to death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
Trial details
NCT IDNCT03596502
SponsorCanadian Network for Observational Drug Effect Studies, CNODES