Atrial FibrillationNCT04593056
Replication of the ROCKET-AF 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 older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Warfarin and Rivaroxaban
- How many people
- 102,636 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 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
- Adult, Older adult
Study population: This study will involve a new user, parallel group, cohort study design comparing rivaroxaban to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of rivaroxaban 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. Patients 18 years of age or older
- 2. Non-valvular atrial fibrillation
- 3. Non-valvular atrial fibrillation 14 days or after the previous diagnosis of AF in inclusion 2
- 4. History of prior ischemic stroke, TIA, systemic embolism or two or more of the following risk factors:
- 4a. Heart failure and/or left ventricular ejection fraction ≤35%
- 4b. Hypertension (defined as use of antihypertensive medications within 6 months before the screening visit or persistent systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg)
- 4c. Patients 75 years of age or older
- 4d. Diabetes mellitus (defined as a history of type 1 or type 2 diabetes mellitus or use of antidiabetic medications within 6 months before screening visit)
Who cannot join
- 1. Cardiac-related conditions
- 1a. Hemodynamically significant mitral valve stenosis
- 1b. Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
- 1e. Known presence of atrial myxoma or left ventricular thrombus
- 1f. Active endocarditis
- 2. Hemorrhage-related risk criteria
Show all 36Show fewer
- 2a. Active internal bleeding
- 2b. History of or condition associated with increased bleeding risk including, but not limited to:
- Major surgical procedure or trauma within 30 days before the randomization visit
- Clinically significant gastrointestinal bleeding within 6 months before the randomization visit
- History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding
- Chronic hemorrhagic disorder
- Known intracranial neoplasm, arteriovenous malformation, or aneurysm
- 2d. Platelet count < <90,000/μL at the screening visit
- 2e. Sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100
- 3. Concomitant conditions and therapies
- 3a. Severe, disabling stroke (modified Rankin score of 4 to 5, inclusive) within 3 months or any stroke within 14 days before the randomization visit
- 3b. Transient ischemic attack within 3 days before the randomization visit
- 3c. Indication for anticoagulant therapy for a condition other than atrial fibrillation (e.g., VTE)
- 3d. Treatment with:
- Aspirin >100 mg daily
- Aspirin in combination with thienopyridines within 5 days before randomization
- Intravenous antiplatelets within 5 days before randomization
- Fibrinolytics within 10 days before randomization
- Note: Aspirin ≤100 mg monotherapy is allowed and thienopyridine monotherapy is allowed.
- 3f. Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors, within 4 days before randomization, or planned treatment during the time period of the study
- 3g. Treatment with a strong inducer of cytochrome P450 3A4, such as rifampin/rifampicin, within 4 days before randomization, or planned treatment during the time period of the study
- 3h. Anemia (hemoglobin <10 g/dL) at the screening visit
- 3i. Pregnancy or breast-feeding
- 3k. Known HIV infection at time of screening
- 3l. Calculated CLCR <30 mL/min at the screening visit (refer to Attachment 4 for calculating CLCR)
- 3m. Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or ALT >3 x the ULN
- 4. Study participation and follow-up-related criteria
- 4a. Serious concomitant illness associated with a life expectancy of less than 2 years
- 4b. Drug addiction or alcohol abuse within 3 years before the randomization visit
- 4f. Inability or unwillingness to comply with study-related procedures
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, Rivaroxaban
- 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
RivaroxabanDrug
Rivaroxaban dispensing claim is used as the exposure
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Reference group Receives: Drug: Warfarin | |
| Rivaroxaban | Exposure group Receives: Drug: Rivaroxaban |
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 98-119 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 Sep 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
- 102,636 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, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593056
- Sponsor's protocol ID
- 2018P002966-DUP-ROCKET-AF
- Status last verified
- Jul 2023
- First submitted
- 13 Oct 2020
- Last updated
- 28 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the ROCKET-AF Anticoagulant Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT04593056
- Acronym / sponsor ID
- 2018P002966-DUP-ROCKET-AF
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102,636 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 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 |
| Rivaroxaban | – | Drug: RivaroxabanExposure group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, cohort study design comparing rivaroxaban to warfarin. The patients will be required to have continuous enrollment during baseline period of 180 days before initiation of rivaroxaban or the comparator drug (cohort entry date). Follow-up for the outcome, begins the day after drug initiation.
Key inclusion criteria (8 listed)
- 1. Patients 18 years of age or older
- 2. Non-valvular atrial fibrillation
- 3. Non-valvular atrial fibrillation 14 days or after the previous diagnosis of AF in inclusion 2
- 4. History of prior ischemic stroke, TIA, systemic embolism or two or more of the following risk factors:
Key exclusion criteria (36 listed)
- 1. Cardiac-related conditions
- 2. Hemorrhage-related risk criteria
- 3. Concomitant conditions and therapies
- 4. Study participation and follow-up-related criteria
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 |
| RivaroxabanRivaroxaban dispensing claim is used as the exposure | Drug | Rivaroxaban |
Primary outcome
Relative hazard of composite outcome of Stroke and Systemic Embolism
Time frame: [Time Frame: Through study completion (a median of 98-119 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 28 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, ScM 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 8 inclusion and 36 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 28 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 98-119 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 28 Jul 2023.