Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare

An observational study of Atrial Fibrillation and Obesity, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who initiate therapy with OACs (oral anti-coagulants). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation, Obesity, Anticoagulants
What is being tested?: Apixaban
How many people: 107,383 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2020to 3 Nov 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Obese or severely obese AF patients in the CMS Medicare and Veterans' Health Affairs (VHA) databases who were newly prescribed OACs between January 1, 2013 and December 31, 2017.

Who may be able to join

Obese or severely obese.
Initiated an OAC from July 1, 2013 - December 31, 2017; the first DOAC pharmacy claim date during the identification period will be designated as the index date. The first warfarin prescription date will be designated as the index date for patients without any DOAC claim.
Individuals ≥18 years old as of the index date.
Had 6 months continuous health plan enrollment with medical benefits (Parts A \& B) for at least 6 months pre-index date (baseline period).
At least 1 diagnosis of AF prior to or on index date, identified by any medical claim associated with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 427.31 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of I480-I482, and I4891.
Had body weight or BMI value reported within ±6 months of the index date.

Who cannot join

Had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient AF 6 months prior to or on the index date.
Had hip/knee replacement surgery within 6 weeks prior to or on the index date.
Were pregnant during the study period.
Had an OAC prescription during the 6 months pre-index date.
Had follow-up time equal to 0 days.
Had more than one OAC on the index date.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer
New York, New York, 10012

Other trials in United States

About this study

Official title: Effectiveness and Safety of Oral Anticoagulants Among Obese Patients With Non-Valvular Atrial Fibrillation in the Veterans Affairs Population With Medicare

However, the primary analysis will be conducted among apixaban vs warfarin patients only. If sample size permits, we will also conduct other DOAC vs warfarin and DOAC vs DOAC analysis.

Conditions: Atrial Fibrillation, Obesity, Anticoagulants
Being tested: Apixaban
Keywords: Medicare, Veterans Affairs, Major Bleeding, Stroke
Medical subject headings: Atrial Fibrillation, Obesity, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApixabanDrug
Also called Eliquis
Anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation.

Study groups in NCT04681482
Study group	Role	What they receive
Apixaban Group		The cohort prescribed apixaban and diagnosed with Atrial Fibrillation Receives: Drug: Apixaban
Warfarin Group		patients prescribed warfarin only diagnosed with Atrial Fibrillation.

What is being measured

The primary outcome is the main question the study is designed to answer.

Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants
Event rate per 100 participant-years for first occurrence of major bleeding (MB) event after index date in obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017 [3.5 years]). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of gastrointestinal (GI), intracranial hemorrhage (ICH), and other sites. MB was equal to 1 if bleeding event was greater than equal to (>=) 1.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants
Event rate per 100 participant-years for first occurrence of MB event after index date in morbidly obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of GI, ICH, and other sites. MB was equal to 1 if bleeding event was >=1.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Charlson Comorbidity Index (CCI)
CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity.
Measured: Baseline (6 months prior to index date)

Secondary outcomes (1)

Time in Therapeutic Range (TTR) During Follow-up Period
TTR was computed using INR values among warfarin participants during the follow-up. TTR was calculated based on the percentage of time a participant remained in therapeutic range evaluated during the entire follow-up period. TTR >=65 percent (%) was observed as good and TTR less than (<) 65% was observed as poor.
Measured: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 20203 Nov 2020

First posted23 Dec 2020
Study start2 Nov 2020
Primary completion3 Nov 2020
Study completion3 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by PfizerThe 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: 107,383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04681482
Sponsor's protocol ID: B0661162
Status last verified: May 2023
First submitted: 18 Dec 2020
Last updated: 22 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness and Safety of Oral Anticoagulants Among Obese Patients With Non-Valvular Atrial Fibrillation in the Veterans Affairs Population With Medicare
ClinicalTrials.gov ID: NCT04681482
Acronym / sponsor ID: B0661162
Conditions: Atrial Fibrillation, Obesity, Anticoagulants
Keywords: Medicare, Veterans Affairs, Major Bleeding, Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 107,383 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 2 Nov 2020 (actual)
Primary completion: 3 Nov 2020 (actual)
Study completion: 3 Nov 2020 (actual)
First posted: 23 Dec 2020 (actual)
Results: Posted 6 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

However, the primary analysis will be conducted among apixaban vs warfarin patients only. If sample size permits, we will also conduct other DOAC vs warfarin and DOAC vs DOAC analysis.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Apixaban Group	–	Drug: ApixabanThe cohort prescribed apixaban and diagnosed with Atrial Fibrillation
Warfarin Group	–	–patients prescribed warfarin only diagnosed with Atrial Fibrillation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Obese or severely obese AF patients in the CMS Medicare and Veterans' Health Affairs (VHA) databases who were newly prescribed OACs between January 1, 2013 and December 31, 2017.

Key inclusion criteria (6 listed)

Obese or severely obese.
Initiated an OAC from July 1, 2013 - December 31, 2017; the first DOAC pharmacy claim date during the identification period will be designated as the index date. The first warfarin prescription date will be designated as the index date for patients without any DOAC claim.
Individuals ≥18 years old as of the index date.
Had 6 months continuous health plan enrollment with medical benefits (Parts A \& B) for at least 6 months pre-index date (baseline period).
At least 1 diagnosis of AF prior to or on index date, identified by any medical claim associated with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 427.31 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of I480-I482, and I4891.

Key exclusion criteria (6 listed)

Had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient AF 6 months prior to or on the index date.
Had hip/knee replacement surgery within 6 weeks prior to or on the index date.
Were pregnant during the study period.
Had an OAC prescription during the 6 months pre-index date.
Had follow-up time equal to 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
ApixabanAlso: EliquisAnticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation.	Drug	Apixaban Group

Primary outcome

Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event rate per 100 participant-years for first occurrence of major bleeding (MB) event after index date in obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017 [3.5 years]). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of gastrointestinal (GI), intracranial hemorrhage (ICH), and other sites. MB was equal to 1 if bleeding event was greater than equal to (>=) 1.
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event rate per 100 participant-years for first occurrence of MB event after index date in morbidly obese participants was reported. MB after index date was identified using hospital claims and occurred anytime during the follow-up period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. MB events included the composite of GI, ICH, and other sites. MB was equal to 1 if bleeding event was >=1.
Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.
Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event rate per 100 participant-years for first occurrence of stroke or SE events after index date in morbidly obese participants was reported. Stroke/SE were identified using hospital claims and occurred anytime during the period of drug use or within 30 days from the last day of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim. Stroke events included the composite of any ischemic, any hemorrhagic and SE stroke events. Stroke/SE was equal to 1 if stroke event was >=1.
Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Obese Participants
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.
Event Rate Per 100 Participant-Years For First Occurrence of Net Clinical Benefit After Index Date in Morbidly Obese Participants
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)
Event rate per 100 participant-years for first occurrence of net clinical benefit after index date in morbidly obese participants was reported. For participants with stroke/SE or MB event, net clinical benefit was assessed by evaluating the first hospital claim for a stroke/SE or MB event. The hospital claim occurred anytime during the period of drug use or within 30 days from the last day of supply of treatment prescription. Index date was defined as date of first DOAC pharmacy claim date during the identification period (July 1, 2013-December 31, 2017). The first warfarin prescription date was designated as the index date for participants without any DOAC claim.
Charlson Comorbidity Index (CCI)
Time frame: Baseline (6 months prior to index date)
CCI based on various comorbid conditions such as myocardial infarction, CHF, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity.

1 secondary outcome

Time in Therapeutic Range (TTR) During Follow-up Period
Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)

Results and safety

Results posted to the registry on 6 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Warfarin	35,051	35,051
Apixaban	38,756	38,756
Dabigatran	12,148	12,148
Rivaroxaban	21,428	21,428

Primary outcome: Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants

Time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years). Number. Unit: Events Per 100 Participant-Years

Measure	Warfarin n = 12918	Apixaban n = 13604
Value	7.27	4.06

Warfarin vs Apixaban: Hazard Ratio (HR): 0.62 (95% CI 0.54 to 0.70), p <0.001, Cox Proportional Hazards Model

Population analysed: Obese participants with or without DOAC treatment diagnosed with NVAF were included in the outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Primary outcome: Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Morbidly Obese Participants

Measure	Warfarin n = 2176	Apixaban n = 1746
Value	5.52	3.94

Population analysed: Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in the outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Primary outcome: Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Obese Participants

Measure	Warfarin n = 12918	Apixaban n = 13604
Value	2.09	1.51

Warfarin vs Apixaban: Hazard Ratio (HR): 0.82 (95% CI 0.66 to 1.03), p = 0.088, Cox Proportional Hazards Model

Population analysed: Obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

Primary outcome: Event Rate Per 100 Participant-Years For First Occurrence of Stroke or Systemic Embolism (SE) Events After Index Date in Morbidly Obese Participants

Measure	Warfarin n = 2176	Apixaban n = 1746
Value	1.51	0.92

Population analysed: Morbidly obese participants with or without DOAC treatment diagnosed with NVAF were included in this outcome measure. Analysis performed using IPTW method to balance participant characteristics among reporting groups.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Warfarin	0 of 0	0 of 0
Apixaban	0 of 0	0 of 0
Dabigatran	0 of 0	0 of 0
Rivaroxaban	0 of 0	0 of 0

Limitations and caveats (from the sponsor): Data for Edoxaban drug cohort was not observed due to small sample size, based on Sponsor's decision. Data for creatinine clearance was not recorded and reported due to insufficient amount of data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.

Pfizer CT.gov Call Center study director

Pfizer

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 Obesity, run by Pfizer 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 6 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 22 May 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?

Yes. Results are posted in the registry (first posted 6 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date in Obese Participants (time frame: From first dose of study drug to follow-up period or within 30 days from last prescription date (data collected and observed retrospectively for 3.5 years)). The study lists 7 primary outcomes in all. 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 NCT04681482.

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 22 May 2023.