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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Warfarin | New users of warfarin |
| |
| Dabigatran | New users of dabigatran |
| |
| Rivaroxaban | New users of rivaroxaban |
| |
| Apixaban | New users of apixaban |
| |
| Edoxaban | New users of edoxaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug | Initiation of warfarin, identified using prescription fill in pharmacy claims |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with composite events of stroke or systemic embolism | Stroke OR systemic embolism, identified by relevant diagnoses in the claims data | January 2013 - December 2020 (after drug initiation) |
| Number of patients with major bleeding | Major bleeding, identified by relevant diagnoses in the claims data | January 2013 - December 2020 (after drug initiation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | January 2013 - December 2020 (after drug initiation) |
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Inclusion Criteria:
Exclusion Criteria:
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Study population includes older patients with non-valvular AF who initiates warfarin or a NOAC.
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| Name | Affiliation | Role |
|---|---|---|
| Dae Hyun Kim, MD, MPH, ScD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 5, 2021 |
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| Dabigatran |
| Drug |
Initiation of dabigatran, identified using prescription fill in pharmacy claims |
|
| Rivaroxaban | Drug | Initiation of rivaroxaban, identified using prescription fill in pharmacy claims |
|
| Apixaban | Drug | Initiation of apixaban, identified using prescription fill in pharmacy claims |
|
| Edoxaban | Drug | Initiation of edoxaban, identified using prescription fill in pharmacy claims |
|
| Apr 19, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000073496 | Frailty |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| C552171 | edoxaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
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