Atrial FibrillationSPAFNCT03441633

Apixaban Drug Utilization Study In Stroke Prevention In Atrial Fibrillation (Spaf)

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

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: apixaban, dabigatran and VKA
How many people: 51,690 participants
Where: 1 siteSpain
Study dates: 18 Feb 2016to 8 Mar 2017
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: SIDIAP currently collects information from 274 primary health care centers, including more than 5.8 million patients, about 80 % of the Catalonia population, or more than 10 % of the Spanish population covered by the Catalan Institute of Health. The study population for these cohorts includes all eligible subjects from the source population with a first -recorded prescription of apixaban VKA, dabigatran or rivaroxaban for the SPAF indication, registered in SIDIAP database and diagnosis of NVAF for study period.

Who may be able to join

Patients more than 18 years-old.
Patients diagnosed with NVAF registered in primary care according to ICD-10.
Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
Continuous enrolment in the 12 months pre-index.

Who cannot join

Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
Lost to follow-up (e.g. transfer to primary care center non-ICS).

Trial locations and contacts

1 site in 1 country.

Spain1 site

IDIAP Jordi Gol
Barcelona, Catalonia, 8007

Other trials in Spain

About this study

Official title: APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)

Apixaban is a direct anticoagulant, which inhibits the factor Xa. Its clinical efficiency in prevention of stroke and systemic embolism in adult patients with NVAF (non/valvular atrial fibrillation) was demonstrated as well as has shown better safety profile compared with warfarin. A Drug Utilization study will evaluate whether this drug has been used in accordance with the approved indication and recommendations described in the summary of product characteristics (SmPC) and estimate possible misuse or overuse apixaban.

Read the detailed description

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 1: To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.

Objective 5: To analyze INR (International Normalized Ratio) values during the last 12 months and to obtain TTR (Time in Therapeutic Range) values in patients previously treated with VKA, and during the whole study period for those in the cohort treated with VKA.

Conditions: Atrial Fibrillation
Being tested: apixaban, dabigatran, VKA, rivaroxaban
Keywords: atrial fibrillation, apixaban, stroke
Medical subject headings: Atrial Fibrillation, Stroke

What participants receive

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

apixabanDrug
current or new medication
dabigatranDrug
current or new medication
VKADrug
current or new medication
rivaroxabanDrug
current or new medication

Study groups in NCT03441633
Study group	Role	What they receive
Group 1. Apixaban		Patients who are on treatment with apixaban. 1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 1b. patients who previously have been treated with VKA in the 12 months before index date. Receives: Drug: apixaban
Group 2. VKA		Patients who are on treatment with VKA. 2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 2b. patients who previously have been treated with VKA in the 12 months before index date. Receives: Drug: VKA
Group 3. Dabigatran		Patients who are on treatment with dabigatran. 3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 3b. patients who previously have been treated with VKA in the 12 months before index date. Receives: Drug: dabigatran
Group 4. Rivaroxaban		Patients who are on treatment with rivaroxaban. 4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 4b. patients who previously have been treated with VKA in the 12 months before index date. Receives: Drug: rivaroxaban

What is being measured

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

Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.
Measured: Day 1
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.
Measured: Day 1
Number of Participants by Their Sociodemographic Characteristics: MEDEA
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.
Measured: Day 1
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).
Measured: Day 1
Number of Participants by Comorbidity
Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Measured: Up to 12 months after date of first prescription
Risk of Bleeding Events: HAS-BLED Score
Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, 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 or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year.
Measured: Up to 12 months prior to enrollment
Risk of Thromboembolic Events: CHADS2 Score
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.
Measured: Up to 12 months prior to enrollment
Risk of Thromboembolic Events: CHA2DS2Vasc Score
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.
Measured: Up to 12 months prior to enrollment
Number of Participants by Comedications
Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.
Measured: Up to 30 days after date of first prescription
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)
MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as <80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as >120% of MPR.
Measured: Up to 12 months after date of first prescription
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.
Measured: Up to 12 months after date of first prescription
Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.
Measured: Up to 12 months after date of first prescription
International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
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. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).
Measured: Up to 12 months after date of first prescription
Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). 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. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).
Measured: Up to 12 months after date of first prescription

Timeline

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

18 Feb 20168 Mar 2017

First posted22 Feb 2018
Study start18 Feb 2016
Primary completion8 Mar 2017
Study completion8 Mar 2017

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: 51,690 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03441633
Sponsor's protocol ID: B0661076
Other IDs: SPAF
Acronym: SPAF
Status last verified: Jun 2023
First submitted: 2 Feb 2018
Last updated: 9 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF)
ClinicalTrials.gov ID: NCT03441633
Acronym / sponsor ID: SPAF / B0661076
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, apixaban, stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 51,690 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 18 Feb 2016 (actual)
Primary completion: 8 Mar 2017 (actual)
Study completion: 8 Mar 2017 (actual)
First posted: 22 Feb 2018 (actual)
Results: Posted 19 Apr 2019

Clinical summary

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

Detailed description

The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.

In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.

Objective 2: Describe the level of appropriate usage according to the posology recommended in the apixaban SmPC.

Objective 3: Describe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendations.

Objective 4: Estimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxaban cohort.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Group 1. Apixaban	–	Drug: apixabanPatients who are on treatment with apixaban. 1a. patients who have initiated with apixaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 1b. patients who previously have been treated with VKA in the 12 months before index date.
Group 2. VKA	–	Drug: VKAPatients who are on treatment with VKA. 2a. patients who have initiated with VKA as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 2b. patients who previously have been treated with VKA in the 12 months before index date.
Group 3. Dabigatran	–	Drug: dabigatranPatients who are on treatment with dabigatran. 3a. patients who have initiated with dabigatran as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 3b. patients who previously have been treated with VKA in the 12 months before index date.
Group 4. Rivaroxaban	–	Drug: rivaroxabanPatients who are on treatment with rivaroxaban. 4a. patients who have initiated with rivaroxaban as treatment naïve (no prior prescription of VKA previous to the 12 months before index date). 4b. patients who previously have been treated with VKA in the 12 months before index date.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: SIDIAP currently collects information from 274 primary health care centers, including more than 5.8 million patients, about 80 % of the Catalonia population, or more than 10 % of the Spanish population covered by the Catalan Institute of Health. The study population for these cohorts includes all eligible subjects from the source population with a first -recorded prescription of apixaban VKA, dabigatran or rivaroxaban for the SPAF indication, registered in SIDIAP database and diagnosis of NVAF for study period.

Key inclusion criteria (4 listed)

Patients more than 18 years-old.
Patients diagnosed with NVAF registered in primary care according to ICD-10.
Patients initiating apixaban (naïve or VKA experienced), VKA (naïve or VKA experienced), dabigatran or rivaroxaban for the SPAF indication.
Continuous enrolment in the 12 months pre-index.

Key exclusion criteria (2 listed)

Patients with valvular heart disease (ICD 10: I05.0-I05.09, I08.0-I08.9) including patients with mitral prosthetic valves.
Lost to follow-up (e.g. transfer to primary care center non-ICS).

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
apixabancurrent or new medication	Drug	Group 1. Apixaban
dabigatrancurrent or new medication	Drug	Group 3. Dabigatran
VKAcurrent or new medication	Drug	Group 2. VKA
rivaroxabancurrent or new medication	Drug	Group 4. Rivaroxaban

Primary outcome

Number of Participants by Their Sociodemographic Characteristics: Smoking Habit
Time frame: Day 1
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included smoking habit.
Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit
Time frame: Day 1
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included alcoholic habit.
Number of Participants by Their Sociodemographic Characteristics: MEDEA
Time frame: Day 1
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included MEDEA. MEDEA was a deprivation index that was associated with overall mortality in urban areas. It included factors like job, education, housing conditions and single parent homes. The MEDEA index was categorized in quintiles for urban areas, with quintile 1 corresponding to the least deprived population and quintile 5, the most deprived.
Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
Time frame: Day 1
Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2).
Number of Participants by Comorbidity
Time frame: Up to 12 months after date of first prescription
Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Risk of Bleeding Events: HAS-BLED Score
Time frame: Up to 12 months prior to enrollment
Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, 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 or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year.
Risk of Thromboembolic Events: CHADS2 Score
Time frame: Up to 12 months prior to enrollment
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke.
Risk of Thromboembolic Events: CHA2DS2Vasc Score
Time frame: Up to 12 months prior to enrollment
Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke.
Number of Participants by Comedications
Time frame: Up to 30 days after date of first prescription
Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine.
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Medication Possession Ratio (MPR)
Time frame: Up to 12 months after date of first prescription
MPR was one of the methods of measuring adherence and was defined as the ratio of all days supply to elapsed days, during the 12-month observation period. All days supply defined as sum of number of days supply between the start date and last prescription dispensed. Elapsed days defined as number of days between the start date and the last prescription dispensed. There were three categories of adherence: poor defined as <80% of MPR, good defined as between 80% and 120% of MPR and over adherence defined as >120% of MPR.
Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
Time frame: Up to 12 months after date of first prescription
Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate.
Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
Time frame: Up to 12 months after date of first prescription
NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug.
International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
Time frame: Up to 12 months after date of first prescription
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. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).
Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
Time frame: Up to 12 months after date of first prescription
TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). 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. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (2<INR<3); and risk of hemorrhages (INR>3).

Results and safety

Results posted to the registry on 19 Apr 2019, 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: Naive	4,712	4,712
Apixaban: Non Naive	1,423	1,423
Acenocoumarol: Naive	32,212	32,212
Acenocoumarol: Non-Naive	192	192
Warfarin: Naive	2,286	2,286
Warfarin: Non-Naive	363	363
Dabigatran: Naive	2,855	2,855
Dabigatran: Non-Naive	953	953
Rivaroxaban: Naive	5,132	5,132
Rivaroxaban: Non-Naive	1,562	1,562

Primary outcome: Number of Participants by Their Sociodemographic Characteristics: Smoking Habit

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Apixaban: Naive n = 4712	Apixaban: Non Naive n = 1423	Acenocoumarol: Naive n = 32212	Acenocoumarol: Non-Naive n = 192	Warfarin: Naive n = 2286	Warfarin: Non-Naive n = 363	Dabigatran: Naive n = 2855	Dabigatran: Non-Naive n = 953	Rivaroxaban: Naive n = 5132	Rivaroxaban: Non-Naive n = 1562
Missing	207	23	1844	7	112	14	225	23	354	38
Non-smoker	3104	946	19440	119	1166	234	1684	623	3079	1030
Ex-smoker	459	83	3676	16	320	26	355	72	608	102
Smoker	942	371	7252	50	688	89	591	235	1091	392

Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 0.74 (95% CI 0.68 to 0.82), p = 0.000, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.32 (95% CI 1.14 to 1.52), p = 0.000, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.04 (95% CI 0.93 to 1.17), p = 0.000, Chi-squared

Population analysed: Study population included all participants with a first-recorded prescription of apixaban, VKA, dabigatran or rivaroxaban for SPAF registered in SIDIAP database during the study and diagnosed with NVAF.

Primary outcome: Number of Participants by Their Sociodemographic Characteristics: Alcoholic Habit

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Apixaban: Naive n = 4712	Apixaban: Non Naive n = 1423	Acenocoumarol: Naive n = 32212	Acenocoumarol: Non-Naive n = 192	Warfarin: Naive n = 2286	Warfarin: Non-Naive n = 363	Dabigatran: Naive n = 2855	Dabigatran: Non-Naive n = 953	Rivaroxaban: Naive n = 5132	Rivaroxaban: Non-Naive n = 1562
Missing	2162	353	11299	40	839	91	1263	211	2475	366
No intake	1749	810	14337	111	984	212	1054	550	1696	923
Moderate intake	765	247	6241	39	447	58	505	187	915	255
Risk consumption	36	13	335	2	16	2	33	5	46	18

Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 0.99 (95% CI 0.90 to 1.09), p = 0.000, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.11 (95% CI 0.98 to 1.25), p = 0.000, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.52 (95% CI 0.94 to 2.45), p = 0.164, Chi-squared

Primary outcome: Number of Participants by Their Sociodemographic Characteristics: MEDEA

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Apixaban: Naive n = 4027	Apixaban: Non Naive n = 1210	Acenocoumarol: Naive n = 25477	Acenocoumarol: Non-Naive n = 154	Warfarin: Naive n = 2163	Warfarin: Non-Naive n = 322	Dabigatran: Naive n = 2393	Dabigatran: Non-Naive n = 789	Rivaroxaban: Naive n = 4430	Rivaroxaban: Non-Naive n = 1389
Missing - Urban area	190	90	1754	16	120	28	110	57	230	145
Quintile 1 - Urban area	716	224	4735	31	149	73	558	156	973	230
Quintile 2 - Urban area	754	216	4753	25	315	73	461	148	803	234
Quintile 3 - Urban area	825	256	4801	27	606	52	447	137	904	230
Quintile 4 - Urban area	807	231	4744	28	635	55	429	152	837	300
Quintile 5 - Urban area	735	193	4690	27	338	41	388	139	683	250

Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.36 (95% CI 1.20 to 1.53), p = 0.000, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.01 (95% CI 0.89 to 1.15), p = 0.014, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 0.87 (95% CI 0.77 to 0.99), p = 0.000, Chi-squared

Primary outcome: Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Apixaban: Naive n = 4712	Apixaban: Non Naive n = 1423	Acenocoumarol: Naive n = 32212	Acenocoumarol: Non-Naive n = 192	Warfarin: Naive n = 2286	Warfarin: Non-Naive n = 363	Dabigatran: Naive n = 2855	Dabigatran: Non-Naive n = 953	Rivaroxaban: Naive n = 5132	Rivaroxaban: Non-Naive n = 1562
Missing	1424	261	6898	34	509	87	960	178	1746	311
18.5 - 25 kg per m^2 (Normal)	423	253	4471	30	295	78	272	144	464	271
Less than (<) 18.5 kg per m^2 (Underweight)	12	6	141	0	6	2	10	8	16	0
25 - 30 kg per m^2 (Overweight)	1229	493	10074	68	712	119	735	306	1289	482
Greater than (>) 30 kg per m^2 (Obese)	1624	410	10628	60	764	77	878	317	1617	498

Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.07 (95% CI 0.91 to 1.25), p = 0.000, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 1.38 (95% CI 0.58 to 3.23), p = 0.202, Chi-squared
Apixaban: Naive vs Dabigatran: Naive: Odds Ratio (OR): 0.98 (95% CI 0.88 to 1.09), p = 0.000, Chi-squared

Adverse events

Time frame: Not applicable as safety data was not planned to be collected during the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Apixaban: Naive	0 of 0	0 of 0
Apixaban: Non Naive	0 of 0	0 of 0
Acenocoumarol: Naive	0 of 0	0 of 0
Acenocoumarol: Non-Naive	0 of 0	0 of 0
Warfarin: Naive	0 of 0	0 of 0
Warfarin: Non Naive	0 of 0	0 of 0
Dabigatran: Naive	0 of 0	0 of 0
Dabigatran: Non-Naive	0 of 0	0 of 0
Rivaroxaban: Naive	0 of 0	0 of 0
Rivaroxaban: Non-Naive	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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.

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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.

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 Spain.

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 4 inclusion and 2 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 9 Jun 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 Spain. 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 19 Apr 2019). 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?

Number of Participants by Their Sociodemographic Characteristics: Smoking Habit (time frame: Day 1). The study lists 14 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 NCT03441633.

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 9 Jun 2023.