Atrial FibrillationNCT04435769

Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment

An observational study of Atrial Fibrillation, run by Pfizer at 1 site in Czechia.

Completed

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

Official record

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Trial summary

To describe the direct costs related to warfarin/apixaban treatment Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 109 participants
Where: 1 siteCzechia
Study dates: 4 Aug 2020to 31 May 2021
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: NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.

Who may be able to join

Diagnosis of non-valvular atrial fibrillation (NVAF);
New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
Apixaban arm: genetically determined higher sensitivity to warfarin;
Patients whose status allowed oral treatment with apixaban/warfarin;
Age ≥ 18;
Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.

Who cannot join

Diagnosis of valvular disease;
Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
Contraindications according SmPC of Eliquis

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Fakultní nemocnice Motol
Prague, 150 06

Other trials in Czechia

About this study

Official title: Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment

To describe the direct costs related to warfarin/apixaban treatment

Read the detailed description

To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Conditions: Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

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

Study groups in NCT04435769
Study group	Role	What they receive
Non-valvular Atrial Fibrillation (NVAF) on warfarin		The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.
Non-valvular Atrial Fibrillation (NVAF) on apixaban		The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.

What is being measured

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

CHA2-DS2-VASc Score at Baseline
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Measured: Baseline (from retrospective data retrieved in the study)
HAS-BLED Score at Baseline
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Measured: Baseline (from retrospective data retrieved in the study)
CHA2-DS2-VASc Score at Month 6
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
Measured: Month 6 (from retrospective data retrieved in the study)
HAS-BLED Score at Month 6
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Measured: Month 6 (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Outpatient Visits During First 6 Months of Treatment
Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna [CZK] per visit). Costs were calculated based on the number of outpatient visits during the treatment.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (>=) 20.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of INR Measurements During First 6 Months of Treatment
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Dosage of Warfarin and Apixaban at the Initiation of the Treatment
In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.
Measured: Baseline (from retrospective data retrieved in the study)
Dosage of Warfarin and Apixaban During First 6 Months of Treatment
In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Medication During First 6 Months of Treatment
In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Hospital Admissions
In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Hospital Admissions During First 6 Months of Treatment
In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Number of Diagnostic Procedures
In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment
In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Ischemic Events During First 6 Months of Treatment
Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Major Hemorrhagic Events During First 6 Months of Treatment
Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Number of Participants With Other Adverse Events During First 6 Months of Treatment
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Cost of Other Adverse Events During First 6 Months of Treatment
Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
In this outcome measure, percentage of participants who died due to the given treatment were reported.
Measured: Up to first 6 months of treatment (from retrospective data retrieved in the study)

Timeline

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

4 Aug 202031 May 2021

First posted17 Jun 2020
Study start4 Aug 2020
Primary completion31 May 2021
Study completion31 May 2021

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: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04435769
Sponsor's protocol ID: B0661121
Other IDs: APIXABAN SECOND LINE
Status last verified: May 2022
First submitted: 15 Jun 2020
Last updated: 8 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment
ClinicalTrials.gov ID: NCT04435769
Acronym / sponsor ID: B0661121
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 4 Aug 2020 (actual)
Primary completion: 31 May 2021 (actual)
Study completion: 31 May 2021 (actual)
First posted: 17 Jun 2020 (actual)
Results: Posted 8 Feb 2023

Clinical summary

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

To describe the direct costs related to warfarin/apixaban treatment

Detailed description

To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.

Study design

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

Arm	Type	Receives
Non-valvular Atrial Fibrillation (NVAF) on warfarin	–	–The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.
Non-valvular Atrial Fibrillation (NVAF) on apixaban	–	–The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.

Key inclusion criteria (7 listed)

Diagnosis of non-valvular atrial fibrillation (NVAF);
New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
Apixaban arm: genetically determined higher sensitivity to warfarin;
Patients whose status allowed oral treatment with apixaban/warfarin;

Key exclusion criteria (4 listed)

Diagnosis of valvular disease;
Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
Contraindications according SmPC of Eliquis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

CHA2-DS2-VASc Score at Baseline
Time frame: Baseline (from retrospective data retrieved in the study)
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category, i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
HAS-BLED Score at Baseline
Time frame: Baseline (from retrospective data retrieved in the study)
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
CHA2-DS2-VASc Score at Month 6
Time frame: Month 6 (from retrospective data retrieved in the study)
CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF. CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history). Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
HAS-BLED Score at Month 6
Time frame: Month 6 (from retrospective data retrieved in the study)
HAS-BLED scoring scale was used to estimate the risk of bleeding. HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use). Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
Cost of Outpatient Visits During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of outpatient visits were calculated for the first 6 months of treatment as the number of visits multiplied by the cost of the visit (450.0 Czech koruna [CZK] per visit). Costs were calculated based on the number of outpatient visits during the treatment.
Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. In this outcome measure, percentage of participants were categorized according to number of INR measurements included zero (0), 1 to 9, 10 to 19 and greater than or equal to (>=) 20.
Cost of INR Measurements During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0 CZK per measurement). Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
Dosage of Warfarin and Apixaban at the Initiation of the Treatment
Time frame: Baseline (from retrospective data retrieved in the study)
In this outcome measure, dosage of apixaban and warfarin used at the initiation of treatment was reported.
Dosage of Warfarin and Apixaban During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
Cost of Medication During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, cost of medication, i.e., costs of apixaban and warfarin were based on the dosage of active substance and were calculated for the first 6 months of treatment (daily cost times 182.4 days), regardless of how long the individual participant treated was reported.
Percentage of Participants Categorized According to Number of Hospital Admissions
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
Cost of Hospital Admissions During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization. If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2 CZK per day).
Percentage of Participants Categorized According to Number of Diagnostic Procedures
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
Percentage of Participants Categorized According to Type of Ischemic Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to type of ischemic events which included cardiac ischemia and stroke/TIA.
Cost of Ischemic Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants with major hemorrhagic events which included intracranial bleeding was reported.
Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
Cost of Major Hemorrhagic Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
Number of Participants With Other Adverse Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Other adverse events included all events other than ischemic, major and minor hemorrhagic events.
Cost of Other Adverse Events During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
Time frame: Up to first 6 months of treatment (from retrospective data retrieved in the study)
In this outcome measure, percentage of participants who died due to the given treatment were reported.

Results and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Apixaban	42	42
Warfarin	67	67

Primary outcome: CHA2-DS2-VASc Score at Baseline

Time frame: Baseline (from retrospective data retrieved in the study). Mean (Standard Deviation). Unit: Units on a scale

Measure	Apixaban n = 40	Warfarin n = 63
Value	4.6 (1.5)	4.3 (1.7)

Population analysed: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.

Primary outcome: HAS-BLED Score at Baseline

Time frame: Baseline (from retrospective data retrieved in the study). Mean (Standard Deviation). Unit: Units on a scale

Measure	Apixaban n = 40	Warfarin n = 63
Value	2.7 (1.2)	2.5 (1.1)

Population analysed: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.

Primary outcome: CHA2-DS2-VASc Score at Month 6

Time frame: Month 6 (from retrospective data retrieved in the study). Mean (Standard Deviation). Unit: Units on a scale

Measure	Apixaban n = 40	Warfarin n = 63
Value	5.0 (1.4)	4.9 (1.4)

Population analysed: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.

Primary outcome: HAS-BLED Score at Month 6

Time frame: Month 6 (from retrospective data retrieved in the study). Mean (Standard Deviation). Unit: Units on a scale

Measure	Apixaban n = 40	Warfarin n = 63
Value	3.1 (1.1)	2.8 (1.3)

Population analysed: PP population comprised of participants who followed visit 2 schedule at 6 months (+/- 10 weeks), met all inclusion criteria and did not meet any of the exclusion criteria.

Adverse events

Time frame: 6 Months (from retrospective data retrieved in the study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Apixaban	2 of 42 (4.8%)	4 of 42 (9.5%)	0 of 42
Warfarin	10 of 67 (14.9%)	0 of 67 (0%)	1 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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)
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Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.

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, run by Pfizer at 1 site in Czechia.

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 4 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 8 Feb 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 Czechia. 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 8 Feb 2023). 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?

CHA2-DS2-VASc Score at Baseline (time frame: Baseline (from retrospective data retrieved in the study)). The study lists 23 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 NCT04435769.

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 8 Feb 2023.