Atrial FibrillationNCT04878497
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
An observational study of Atrial Fibrillation and Frailty, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Atrial Fibrillation, Frailty, Anticoagulant-induced Bleeding
- What is being tested?
- Warfarin, Dabigatran and Rivaroxaban
- How many people
- 1,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 31 Dec 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Study population includes older patients with non-valvular AF who initiates warfarin or a NOAC.
Who may be able to join
- Initiation of a NOAC or warfarin (day 0 is the initiation day)
- Continuous enrollment in medical and drug insurance in [-183, 0] days
- Diagnosis of AF in [-183, 0] days
- CHA2DS2-VASc score ≥2 (moderate or high risk for stroke)
- No prior use of NOAC or warfarin in [-183, -1] days
- No recent hospitalization for stroke or major bleeding in [-60, 0] days
- No recent nursing facility stay in [-60, 0] days
Who cannot join
- Contraindication to either drug in [-183, 0] days
- Valvular heart disease or mechanical heart valve in [-183, 0] days
- Intracranial or retroperitoneal hemorrhage in [-183, 0] days
- Chronic kidney disease stage V, end-stage renal disease, or dialysis in [-183, 0] days
- Other indications for anticoagulation therapy in [-183, 0] days
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin K oral anticoagulants (NOAC) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.
Read the detailed description
Data sources of use for this study are: Medicare Database, Optum Database, and MarketScan Research Database. All data from years 2013-2020 (available data may vary depending on the database) will be analyzed in the study.
This study follows a sequential cohort monitoring design. The monitoring analysis will include 1) retrospective analysis of available data (2013-2018) at the time of first analysis (April 2021) and 2) prospective analysis of new data (2019-2020) as they become available to the researchers. Within each database and by frailty status (frail vs non-frail), the investigators will emulate annual updating of data by creating a propensity score (PS)-matched cohort of new users every 1-year interval. Each sequential cohort will be followed for development of the outcomes of interest. At the end of each interval, time-to-event data from all sequential cohorts will be pooled for outcome analysis. The surveillance will be performed by frailty status (frail vs non-frail) at the time of drug initiation.
- Conditions
- Atrial Fibrillation, Frailty, Anticoagulant-induced Bleeding, Stroke
- Being tested
- Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban
- Medical subject headings
- Atrial Fibrillation, Frailty, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Initiation of warfarin, identified using prescription fill in pharmacy claims
DabigatranDrug
Initiation of dabigatran, identified using prescription fill in pharmacy claims
RivaroxabanDrug
Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
ApixabanDrug
Initiation of apixaban, identified using prescription fill in pharmacy claims
EdoxabanDrug
Initiation of edoxaban, identified using prescription fill in pharmacy claims
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | New users of warfarin Receives: Drug: Warfarin | |
| Dabigatran | New users of dabigatran Receives: Drug: Dabigatran | |
| Rivaroxaban | New users of rivaroxaban Receives: Drug: Rivaroxaban | |
| Apixaban | New users of apixaban Receives: Drug: Apixaban | |
| Edoxaban | New users of edoxaban Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with composite events of stroke or systemic embolism
Stroke OR systemic embolism, identified by relevant diagnoses in the claims data
Measured: January 2013 - December 2020 (after drug initiation)
Number of patients with major bleeding
Major bleeding, identified by relevant diagnoses in the claims data
Measured: January 2013 - December 2020 (after drug initiation)
Secondary outcomes (1)
Number of patients with all-cause mortality
All-cause mortality is defined by the National Death Index file or vital status information in the claims data.
Measured: January 2013 - December 2020 (after drug initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start30 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- 1,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Hyun Kim, MD, MPH, ScD, Brigham and Women's Hospital
- Investigators
- Dae Hyun Kim, MD, MPH, ScD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878497
- Sponsor's protocol ID
- 2019P000110-NOAC
- Status last verified
- May 2021
- First submitted
- 22 Apr 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
- ClinicalTrials.gov ID
- NCT04878497
- Acronym / sponsor ID
- 2019P000110-NOAC
- Conditions
- Atrial Fibrillation, Frailty, Anticoagulant-induced Bleeding, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 May 2021 (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 objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin K oral anticoagulants (NOAC) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.
Detailed description
Data sources of use for this study are: Medicare Database, Optum Database, and MarketScan Research Database. All data from years 2013-2020 (available data may vary depending on the database) will be analyzed in the study.
This study follows a sequential cohort monitoring design. The monitoring analysis will include 1) retrospective analysis of available data (2013-2018) at the time of first analysis (April 2021) and 2) prospective analysis of new data (2019-2020) as they become available to the researchers. Within each database and by frailty status (frail vs non-frail), the investigators will emulate annual updating of data by creating a propensity score (PS)-matched cohort of new users every 1-year interval. Each sequential cohort will be followed for development of the outcomes of interest. At the end of each interval, time-to-event data from all sequential cohorts will be pooled for outcome analysis. The surveillance will be performed by frailty status (frail vs non-frail) at the time of drug initiation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Warfarin | – | Drug: WarfarinNew users of warfarin |
| Dabigatran | – | Drug: DabigatranNew users of dabigatran |
| Rivaroxaban | – | Drug: RivaroxabanNew users of rivaroxaban |
| Apixaban | – | Drug: ApixabanNew users of apixaban |
| Edoxaban | – | Drug: EdoxabanNew users of edoxaban |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Study population includes older patients with non-valvular AF who initiates warfarin or a NOAC.
Key inclusion criteria (7 listed)
- Initiation of a NOAC or warfarin (day 0 is the initiation day)
- Continuous enrollment in medical and drug insurance in [-183, 0] days
- Diagnosis of AF in [-183, 0] days
- CHA2DS2-VASc score ≥2 (moderate or high risk for stroke)
- No prior use of NOAC or warfarin in [-183, -1] days
Key exclusion criteria (5 listed)
- Contraindication to either drug in [-183, 0] days
- Valvular heart disease or mechanical heart valve in [-183, 0] days
- Intracranial or retroperitoneal hemorrhage in [-183, 0] days
- Chronic kidney disease stage V, end-stage renal disease, or dialysis in [-183, 0] days
- Other indications for anticoagulation therapy in [-183, 0] days
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 |
|---|---|---|
| WarfarinInitiation of warfarin, identified using prescription fill in pharmacy claims | Drug | Warfarin |
| DabigatranInitiation of dabigatran, identified using prescription fill in pharmacy claims | Drug | Dabigatran |
| RivaroxabanInitiation of rivaroxaban, identified using prescription fill in pharmacy claims | Drug | Rivaroxaban |
| ApixabanInitiation of apixaban, identified using prescription fill in pharmacy claims | Drug | Apixaban |
| EdoxabanInitiation of edoxaban, identified using prescription fill in pharmacy claims | Drug | Edoxaban |
Primary outcome
Number of patients with composite events of stroke or systemic embolism
Time frame: January 2013 - December 2020 (after drug initiation)
Stroke OR systemic embolism, identified by relevant diagnoses in the claims data
Number of patients with major bleeding
Time frame: January 2013 - December 2020 (after drug initiation)
Major bleeding, identified by relevant diagnoses in the claims data
1 secondary outcome
Number of patients with all-cause mortality
Time frame: January 2013 - December 2020 (after drug initiation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Individual participant dataSharing planned: No
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Paroxysmal AF
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Atrial Fibrillation (AF)
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.
Dae Hyun Kim, MD, MPH, ScD 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 and Frailty, 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 May 2021. 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?
Results are not available in the source record.
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?
Number of patients with composite events of stroke or systemic embolism (time frame: January 2013 - December 2020 (after drug initiation)). The study lists 2 primary outcomes in all. 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 7 May 2021.