Atrial FibrillationNCT03596502
Direct Oral Anticoagulants in Patients With Atrial Fibrillation (DOACs vs Warfarin)
An observational study of Atrial Fibrillation and Ischemic Stroke, run by Canadian Network for Observational Drug Effect Studies, CNODES at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ischemic Stroke, Systemic Embolization
- What is being tested?
- Direct oral anticoagulants (DOACs) and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 402,764 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 1 Dec 2018
- 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 newly anticoagulated from the date of the first DOAC approval for stroke prevention in AF (in each site) to the date of the latest data availability at each site, that had a diagnosis of AF within the 3 years prior to the date of the prescription.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X 0A9
About this study
Official title: Safety and Effectiveness of Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation: a Multi-database Cohort Study With Meta-analysis (DOACs vs Warfarin)
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.
Read the detailed description
The objective 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).
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from seven Canadian provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, Saskatchewan). 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 Alberta, Nova Scotia, and Ontario will be restricted to patients aged 65 years and older, as prescription data are not available for younger patients.
In each jurisdiction, the investigators will assemble a base cohort that includes all patients newly prescribed an oral anticoagulant (DOAC or warfarin) for stroke prevention in AF. Study period will be from the date of the first DOAC approval for stroke prevention in AF at each site to the date of latest data availability at each site. All patients newly dispensed an oral anticoagulant (i.e. with no prescription for any oral anticoagulant in the prior year) with a diagnosis of AF within the 3 years prior to the date of the prescription will be eligible to be included into the study cohorts, given they present no exclusion criteria. The date of study cohort entry will be defined by the dispensation date of the newly prescribed oral anticoagulant. Patients will be censored at the earliest of death, end of healthcare coverage, switch from DOAC to warfarin, switch from warfarin to DOAC, initiation of hemodialysis or heart valve surgery, or the end of the study period, whichever occurs first.
Exposure to a DOAC will be defined as a new prescription for a DOAC (apixaban, dabigatran, rivaroxaban) 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 ischemic stroke or systemic embolization. The secondary outcomes will be: 1) major bleeding; 2) a composite of stroke (ischemic or hemorrhagic), systemic embolization, major bleeding or all-cause mortality; 3) myocardial infarction; 4) gastrointestinal bleeding; 5) intracranial bleeding; and 6) all-cause mortality.
The study cohort will be analyzed using a matched cohort design, where DOAC users will be matched 1:1 to warfarin users 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 differences at the time of cohort entry). Cox-proportional hazards regression models will be used to estimate adjusted hazards ratios (HRs) and corresponding 95% confidence intervals (CIs) for ischemic stroke or systemic embolization in the three cohorts. Meta-analyses of the site-specific results will be performed using random effects models. As secondary analyses, the composite outcome will be stratified by age (<85 and ≥85) and sex. In addition, an as treated analysis using inverse probability of censoring weights (IPCW) will be performed to account for non-random censoring.
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Systemic Embolization, Major Bleed, Myocardial Infarction, All-cause Mortality
- Being tested
- Direct oral anticoagulants (DOACs), Warfarin
- Keywords
- Direct oral anticoagulants, Safety, Atrial fibrillation, Ischemic stroke, Systemic embolization
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct oral anticoagulants (DOACs)Drug
Also called Eliquis, Pradaxa, Xarelto
Exposure to DOACs will be defined as a new prescription for apixaban (ATC B01AF02), dabigatran (ATC B01AE07), or rivaroxaban (ATC B01AF01) at cohort entry date in patients diagnosed with non-valvular atrial fibrillation.
WarfarinDrug
Also called Coumadin
Exposure to warfarin will be defined as a new prescription for warfarin (ATC B01AA03) at cohort entry date in patients diagnosed with non-valvular atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Direct oral anticoagulants (DOACs) | Patients diagnosed with non-valvular atrial fibrillation who initiated their oral anticoagulation with a DOAC (apixaban, dabigatran or rivaroxaban) at cohort entry date, and did not have a previous prescription for any oral anticoagulant in the prior year. Receives: Drug: Direct oral anticoagulants (DOACs) | |
| Warfarin | Patients diagnosed with non-valvular atrial fibrillation who initiated their oral anticoagulation with warfarin at cohort entry date, and did not have a previous prescription for any oral anticoagulant in the prior year. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke (IS) or systemic embolization (SE)
Patients hospitalized or visiting the emergency department (ED) for a stroke or a systemic embolization recorded as the most responsible diagnosis in either the discharge abstract or hospitalization record with the following ICD codes:
Ischemic stroke:
ICD-9 codes: 434.x; ICD-10 codes: I63.x, I64.x
Systemic embolization:
ICD-9 codes: 444.x; ICD-10 codes: I74.x
Measured: 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.
Secondary outcomes (3)
Major bleeding
Patients hospitalized or visiting the emergency department (ED) for a major bleed composite recorded as the most responsible diagnosis in either the discharge abstract or hospitalization record with the following ICD codes:
Intracranial bleeding (including hemorrhagic stroke):
ICD-9 codes: 430.x, 431.x, 432.x; ICD-10 codes: I60.x, I61.x, I62.x
Gastrointestinal bleeding:
ICD-9 codes: 456.0, 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, 569.3, 578.x; ICD-10 codes: I85.0, I98.3, 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, K55.21, K62.5, K63.81, K92.0, K92.1, K92.2
Ocular bleeding:
ICD-9 codes: 362.81, 363.6x, 376.32, 379.23, 377.42; ICD-10 codes: H31.3, H35.6, H43.1, H45.0
Other bleeding causing ED visit or hospitalization:
ICD-9 codes: 459.0, 596.7, 599.7, 627.1, 719.1, 729.92, 784.7, 784.8, 786.3; ICD-10 codes: D68.3, K66.1, M25.0x, N02.x
Measured: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until a hospitalization or ED visit for major bleed, censoring due to death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
All-cause mortality
Measured: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
Myocardial infarction
Patients hospitalized for a myocardial infarction recorded as the most responsible diagnosis in hospitalization record with the following ICD codes:
ICD-9 codes: 410.x; ICD-10 codes: I21.x
Measured: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until a hospitalization for a myocardial infarction, censoring due to death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Feb 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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 Atrial FibrillationStudies 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
- 402,764 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
- Madeleine Durand, MD, MSc, FRCPC, Principal investigator, Centre de Recherche du Centre Hospitalier de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596502
- Sponsor's protocol ID
- Q16-13B
- Status last verified
- Jan 2021
- First submitted
- 12 Jul 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durand M, Schnitzer ME, Pang M, Carney G, Eltonsy S, Filion KB, Fisher A, Jun M, Kuo IF, Renoux C, Paterson JM, Quail J, Matteau A; Canadian Network for Observational Drug Effect Studies Investigators. Comparative effectiveness and safety of direct oral anticoagulants versus vitamin K antagonists in nonvalvular atrial fibrillation: a Canadian multicentre observational cohort study. CMAJ Open. 2020 Dec 18;8(4):E877-E886. doi: 10.9778/cmajo.20200055. Print 2020 Oct-Dec.
PubMed 33355273
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation: a Multi-database Cohort Study With Meta-analysis (DOACs vs Warfarin)
- ClinicalTrials.gov ID
- NCT03596502
- Acronym / sponsor ID
- Q16-13B
- Conditions
- Atrial Fibrillation, Ischemic Stroke, Systemic Embolization, Major Bleed, Myocardial Infarction, All-cause Mortality
- Keywords
- Direct oral anticoagulants, Safety, Atrial fibrillation, Ischemic stroke, Systemic embolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402,764 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
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- 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 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.
Detailed description
The objective 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).
A common-protocol approach will be used to conduct retrospective cohort studies using administrative health care data from seven Canadian provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, Quebec, Saskatchewan). 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 Alberta, Nova Scotia, and Ontario will be restricted to patients aged 65 years and older, as prescription data are not available for younger patients.
In each jurisdiction, the investigators will assemble a base cohort that includes all patients newly prescribed an oral anticoagulant (DOAC or warfarin) for stroke prevention in AF. Study period will be from the date of the first DOAC approval for stroke prevention in AF at each site to the date of latest data availability at each site. All patients newly dispensed an oral anticoagulant (i.e. with no prescription for any oral anticoagulant in the prior year) with a diagnosis of AF within the 3 years prior to the date of the prescription will be eligible to be included into the study cohorts, given they present no exclusion criteria. The date of study cohort entry will be defined by the dispensation date of the newly prescribed oral anticoagulant. Patients will be censored at the earliest of death, end of healthcare coverage, switch from DOAC to warfarin, switch from warfarin to DOAC, initiation of hemodialysis or heart valve surgery, or the end of the study period, whichever occurs first.
Exposure to a DOAC will be defined as a new prescription for a DOAC (apixaban, dabigatran, rivaroxaban) 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 ischemic stroke or systemic embolization. The secondary outcomes will be: 1) major bleeding; 2) a composite of stroke (ischemic or hemorrhagic), systemic embolization, major bleeding or all-cause mortality; 3) myocardial infarction; 4) gastrointestinal bleeding; 5) intracranial bleeding; and 6) all-cause mortality.
The study cohort will be analyzed using a matched cohort design, where DOAC users will be matched 1:1 to warfarin users 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 differences at the time of cohort entry). Cox-proportional hazards regression models will be used to estimate adjusted hazards ratios (HRs) and corresponding 95% confidence intervals (CIs) for ischemic stroke or systemic embolization in the three cohorts. Meta-analyses of the site-specific results will be performed using random effects models. As secondary analyses, the composite outcome will be stratified by age (<85 and ≥85) and sex. In addition, an as treated analysis using inverse probability of censoring weights (IPCW) will be performed to account for non-random censoring.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct oral anticoagulants (DOACs) | – | Drug: Direct oral anticoagulants (DOACs)Patients diagnosed with non-valvular atrial fibrillation who initiated their oral anticoagulation with a DOAC (apixaban, dabigatran or rivaroxaban) at cohort entry date, and did not have a previous prescription for any oral anticoagulant in the prior year. |
| Warfarin | – | Drug: WarfarinPatients diagnosed with non-valvular atrial fibrillation who initiated their oral anticoagulation with warfarin at cohort entry date, and did not have a previous prescription for any oral anticoagulant in the prior year. |
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 newly anticoagulated from the date of the first DOAC approval for stroke prevention in AF (in each site) to the date of the latest data availability at each site, that had a diagnosis of AF within the 3 years prior to the date of the prescription.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Direct oral anticoagulants (DOACs)Also: Eliquis, Pradaxa, XareltoExposure to DOACs will be defined as a new prescription for apixaban (ATC B01AF02), dabigatran (ATC B01AE07), or rivaroxaban (ATC B01AF01) at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. | Drug | Direct oral anticoagulants (DOACs) |
| WarfarinAlso: CoumadinExposure to warfarin will be defined as a new prescription for warfarin (ATC B01AA03) at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. | Drug | Warfarin |
Primary outcome
Ischemic stroke (IS) or systemic embolization (SE)
Time frame: 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.
Patients hospitalized or visiting the emergency department (ED) for a stroke or a systemic embolization recorded as the most responsible diagnosis in either the discharge abstract or hospitalization record with the following ICD codes: Ischemic stroke: ICD-9 codes: 434.x; ICD-10 codes: I63.x, I64.x Systemic embolization: ICD-9 codes: 444.x; ICD-10 codes: I74.x
3 secondary outcomes
Major bleeding
Time frame: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until a hospitalization or ED visit for major bleed, censoring due to death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
All-cause mortality
Time frame: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
Myocardial infarction
Time frame: Patients will be followed from date of first DOAC or warfarin prescription (cohort entry date) until a hospitalization for a myocardial infarction, censoring due to death, end of healthcare coverage, or for up to 65 months, whichever occurs first.
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 19 Sep 2024.
- Results publication: PubMed 33355273Durand M, Schnitzer ME, Pang M, Carney G, Eltonsy S, Filion KB, Fisher A, Jun M, Kuo IF, Renoux C, Paterson JM, Quail J, Matteau A; Canadian Network for Observational Drug Effect Studies Investigators. Comparative effectiveness and safety of direct oral anticoagulants versus vitamin K antagonists in nonvalvular atrial fibrillation: a Canadian multicentre observational cohort study. CMAJ Open. 2020 Dec 18;8(4):E877-E886. doi: 10.9778/cmajo.20200055. Print 2020 Oct-Dec.
- This is the website describing the general functions of the organization, other CNODES projects, and investigator profiles.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Madeleine Durand, MD, MSc, FRCPC principal investigator
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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 Atrial Fibrillation and Ischemic Stroke, 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 2 inclusion and 6 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 19 Sep 2024. 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?
Ischemic stroke (IS) or systemic embolization (SE) (time frame: 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.). 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 NCT03596502, 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 19 Sep 2024.