Atrial FibrillationNCT04593043
Replication of the RELY Anticoagulant Trial in Healthcare Claims Data
An observational study of Atrial Fibrillation, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Warfarin and Dabigatran
- How many people
- 78,140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 18 Feb 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will involve a new user, parallel group, cohort study design comparing dabigatran to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of dabigatran or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation.
Who may be able to join
- 1. AF documented as follows: (1a or 1b or 1c)
- 1a. There is ECG documented AF on the day of screening or randomization
- 1b. The patient has had a symptomatic episode of paroxysmal or persistent AF documented by 12-lead ECG within 6 m before randomization
- 1c. There is documentation of symptomatic or asymptomatic paroxysmal or persistent AF on 2 separate occasions, at least 1 day apart, one of which is within 6 m before randomization.
- 2. In addition to documented AF, patients must have one of the following: (2a or 2b or 2c or 2d or 2e)
- 2a. History of previous stroke, TIA, or systemic embolism
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- 2b. Ejection fraction <40% documented by echocardiogram, radionuclide or contrast angiogram in the last 6 m
- 2c. Symptomatic heart failure, New York Heart Association class 2 or higher in the last 6 m
- 2d. Age ≥75 y
- 2e. Age ≥65 y and one of the following:
- Diabetes mellitus on treatment
- Documented coronary artery disease (any of: prior myocardial infarction, positive stress test, positive nuclear perfusion study, prior CABG surgery or PCI, angiogram showing ≥75% stenosis in a major coronary artery
- Hypertension requiring medical treatment
- 3. Age >18 y at entry
Who cannot join
- 1. History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
- 2. Severe, disabling stroke within the previous 6 months or Any stroke within the previous 14 days
- 3. Conditions associated with an increased risk of bleeding:
- 3a. Major surgery in the previous month
- 3c. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
- 3d. Gastrointestinal hemorrhage within the past year
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- 3e. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
- 3f. Hemorrhagic disorder or bleeding diathesis
- 3i. Uncontrolled hypertension (systolic blood pressure >180 mm Hg and/ or diastolic blood pressure >100 mm Hg)
- 7. Severe renal impairment (estimated creatinine clearance ≤30 mL/min)
- 8. Active infective endocarditis
- 9. Active liver disease
- 10. Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
- 11. Anemia (hemoglobin level < 100g/L) or thrombocytopenia (platelet count <100 × 109/L)
- 14. Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trial because of concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (eg, drug addiction, alcohol abuse)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham And Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- Atrial Fibrillation
- Being tested
- Warfarin, Dabigatran
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Warfarin dispensing claim is used as the reference
DabigatranDrug
Dabigatran dispensing claim is used as the exposure
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Reference group Receives: Drug: Warfarin | |
| Dabigatran | Exposure group Receives: Drug: Dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative hazard of composite outcome of Stroke and Systemic Embolism
Relative hazard of composite outcome of Stroke and Systemic Embolism - Please refer to uploaded protocol for full definition due to size limitations.
Measured: [Time Frame: Through study completion (a median of 98 days)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Jan 2020
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- 78,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593043
- Sponsor's protocol ID
- 2018P002966-DUP-RELY
- Status last verified
- Jul 2023
- First submitted
- 13 Oct 2020
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the RELY Anticoagulant Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT04593043
- Acronym / sponsor ID
- 2018P002966-DUP-RELY
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78,140 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 19 Oct 2020 (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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin | – | Drug: WarfarinReference group |
| Dabigatran | – | Drug: DabigatranExposure group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, cohort study design comparing dabigatran to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of dabigatran or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation.
Key inclusion criteria (14 listed)
- 1. AF documented as follows: (1a or 1b or 1c)
- 2. In addition to documented AF, patients must have one of the following: (2a or 2b or 2c or 2d or 2e)
- 3. Age >18 y at entry
Key exclusion criteria (15 listed)
- 1. History of heart valve disorders (ie, prosthetic valve or hemodynamically relevant valve disease)
- 2. Severe, disabling stroke within the previous 6 months or Any stroke within the previous 14 days
- 3. Conditions associated with an increased risk of bleeding:
- 7. Severe renal impairment (estimated creatinine clearance ≤30 mL/min)
- 8. Active infective endocarditis
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 |
|---|---|---|
| WarfarinWarfarin dispensing claim is used as the reference | Drug | Warfarin |
| DabigatranDabigatran dispensing claim is used as the exposure | Drug | Dabigatran |
Primary outcome
Relative hazard of composite outcome of Stroke and Systemic Embolism
Time frame: [Time Frame: Through study completion (a median of 98 days)]
Relative hazard of composite outcome of Stroke and Systemic Embolism - Please refer to uploaded protocol for full definition due to size limitations.
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 27 Jul 2023.
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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.
Shirley Wang, PhD principal investigator
Brigham and Women's Hospital
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, run by Brigham and Women's Hospital at 1 site in United States.
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 14 inclusion and 15 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 27 Jul 2023. 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 United States. 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?
Relative hazard of composite outcome of Stroke and Systemic Embolism (time frame: [Time Frame: Through study completion (a median of 98 days)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.