Non-valvular Atrial FibrillationCER3NCT03570047

Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation

An observational study of Non-valvular Atrial Fibrillation, run by Pfizer at 1 site in Japan.

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: Non-valvular Atrial Fibrillation
How many people: 73,989 participants
Where: 1 siteJapan
Study dates: 8 May 2018to 31 Oct 2018
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: Patients with NVAF who initiated any of oral anti-coagulants

Who may be able to join

Patients must meet all of the following criteria to be eligible for the study:
Diagnosed with AF anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
Prescribed one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
No use of the any OACs during the baseline period (the 180 days before the index date)
Age of 18 years or older on the index date.

Who cannot join

Patients meeting any of the following criteria will not be included in the study:
1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. Having a cardiac surgery procedure record during the baseline period 3. Having a joint replacement procedure record during the baseline period 4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a diagnosis of venous thromboembolism during the baseline period 6. Female patients with pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
-

Trial locations and contacts

1 site in 1 country.

Japan1 site

Pfizer Japan
Tokyo

Other trials in Japan

About this study

Official title: SAFETY AND EFFECTIVENESS EVALUATION OF PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION TREATED WITH OACS: COMPARISON BETWEEN NOACS AND WARFARIN (CER3)

Read the detailed description

An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin K antagonist oral anticoagulants (NOACs). However, its safety and effectiveness remains unknown in real-world clinical practice in Japan. This study will evaluate the risk of stroke/SE as well as the risk of bleeding in the real world settings in Japan in patients with NVAF who initiated any of OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin)

Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation, NVAF

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 Stroke and Systemic Embolism Events After Index Date
Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date
Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date
Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have "any bleeding" if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years

Secondary outcomes (7)

Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date
Event rate per 100 participant-years for first occurrence of ischemic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date
Event rate per 100 participant-years for first occurrence of hemorrhagic stroke after index date was reported. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date
Event rate per 100 participant-years for first occurrence of systemic embolism events after index date was reported. Systemic embolism events included any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date
Event rate per 100 participant-years for first occurrence of major gastrointestinal bleeding events after index date was reported. Major gastrointestinal bleeding after index date was identified using hospital claims which had a gastrointestinal bleeding diagnosis code as the first listed ICD-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date
Event rate per 100 participant-years for first occurrence of any gastrointestinal bleeding event after index date was reported. Any gastrointestinal bleeding was defined by ICD-10 diagnosis codes. If participants had ICD-10 diagnosis codes which suggest bleeding from the gastrointestinal tract, they were considered to have any gastrointestinal bleeding. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date
Event rate per 100 participant-years for first occurrence of major intracranial hemorrhage events after index date was reported. Major intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "major intracranial hemorrhage" if pre-defined major intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date
Event rate per 100 participant-years for first occurrence of any intracranial hemorrhage event after index date was reported. Any intracranial hemorrhage was defined by ICD-10 diagnosis codes and participants were considered to have "any intracranial hemorrhagic event" if pre-defined any intracranial hemorrhagic-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Measured: During the observation period of approximately 7 years

Timeline

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

8 May 201831 Oct 2018

First posted26 Jun 2018
Study start8 May 2018
Primary completion31 Oct 2018
Study completion31 Oct 2018

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 Non-valvular 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: 73,989 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03570047
Sponsor's protocol ID: B0661120
Other IDs: CER3
Acronym: CER3
Status last verified: Oct 2019
First submitted: 15 Jun 2018
Last updated: 4 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
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
An Early Feasibility Study Evaluating the Safety and Efficacy of the Laminar Left Atrial Appendage Closure System in Subjects With Non-Valvular Atrial Fibrillation
Non-valvular Atrial Fibrillation
Active, not recruiting
CHAMPION-AF Clinical Trial
Atrial Fibrillation, Stroke
Not yet recruitingPhase 2
Vortosiran in Atrial Fibrillation
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Active, not recruitingObservational study
WATCHMAN FLX Pro European Registry
Non-valvular Atrial Fibrillation (AF), Left Atrial Appendage Closure
Active, not recruiting
LAmbre™ II Left Atrial Appendage Occluder and Occluder Delivery System for Patients With Non-Valvular Atrial Fibrillation
Non Valvular Atrial Fibrillation

All Non-valvular Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SAFETY AND EFFECTIVENESS EVALUATION OF PATIENTS WITH NON-VALVULAR ATRIAL FIBRILLATION TREATED WITH OACS: COMPARISON BETWEEN NOACS AND WARFARIN (CER3)
ClinicalTrials.gov ID: NCT03570047
Acronym / sponsor ID: CER3 / B0661120
Conditions: Non-valvular Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation, NVAF
Study type: Observational
Recruitment status: Completed
Enrolment: 73,989 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 8 May 2018 (actual)
Primary completion: 31 Oct 2018 (actual)
Study completion: 31 Oct 2018 (actual)
First posted: 26 Jun 2018 (actual)
Results: Posted 4 Nov 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

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with NVAF who initiated any of oral anti-coagulants

Key inclusion criteria (5 listed)

Diagnosed with AF anytime in the baseline period or on the index date, also have definitive diagnosis of AF anytime in the baseline period, on the index date, or post-index period.
Prescribed one of the index OACs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of AF diagnosis. The first observed prescription will be used to identify the patient's index date and treatment cohort
No use of the any OACs during the baseline period (the 180 days before the index date)
Age of 18 years or older on the index date.

Key exclusion criteria (3 listed)

1. Having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. Having a cardiac surgery procedure record during the baseline period 3. Having a joint replacement procedure record during the baseline period 4. Having a procedure of prosthetic heart valve during the baseline period 5. Having a diagnosis of venous thromboembolism during the baseline period 6. Female patients with pregnancy during the follow-up period 7. Patients prescribed "off-label" doses of OACs (per Japanese package insert of each OAC) or patients treated with OAC but in "off-label" or "contraindicated" manners.
-

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

Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date
Time frame: During the observation period of approximately 7 years
Event rate per 100 participant-years for first occurrence of stroke and systemic embolism events after index date was reported. Stroke events included the composite of any ischemic and any hemorrhagic stroke events (non-traumatic extradural hemorrhage). Systemic embolism events were defined as any of the following: abdominal aortic embolism, aortic embolism, acute arterial occlusive disease of arteries of upper extremities, femoral arterial occlusion and acute arterial occlusive disease of arteries of lower extremities, iliac artery embolism, hepatic artery embolism, thromboembolism, embolic infarction, aortic embolism, subclavian artery stenosis. Index date was defined as date of first prescription of any OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Event Rate Per 100 Participant-Years For First Occurrence of Major Bleeding Events After Index Date
Time frame: During the observation period of approximately 7 years
Event rate per 100 participant-years for first occurrence of major bleeding event after index date was reported. Major bleeding after index date was identified using hospital claims which had a bleeding diagnosis code as the first listed in International Statistical Classification of Diseases and Related Health Problems (ICD)-10 diagnosis code. An event occurrence of major bleeding was defined as that appears as "21: Disease name behind hospitalization" in database. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.
Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date
Time frame: During the observation period of approximately 7 years
Event rate per 100 participant-years for first occurrence of any bleeding event after index date was reported. Any bleeding was defined using ICD-10 diagnosis codes and participants were considered to have "any bleeding" if pre-defined bleeding-associated ICD-10 diagnosis codes appeared in the records. Index date was defined as the date of the first prescription of any of OACs (warfarin, apixaban, dabigatran, rivaroxaban or edoxaban) during the observation period of approximately 7 years (2011-2017). Pseudo datasets refers to number derived using IPTW method and are different from the actual participants included in the reporting arm.

7 secondary outcomes

Event Rate Per 100 Participant-Years For First Occurrence of Ischemic Stroke After Index Date
Time frame: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Hemorrhagic Stroke After Index Date
Time frame: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Systemic Embolism Events After Index Date
Time frame: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Major Gastrointestinal Bleeding Events After Index Date
Time frame: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Any Gastrointestinal Bleeding Event After Index Date
Time frame: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Major Intracranial Hemorrhage Events After Index Date
Time frame: During the observation period of approximately 7 years
Event Rate Per 100 Participant-Years For First Occurrence of Any Intracranial Hemorrhage Event After Index Date
Time frame: During the observation period of approximately 7 years

Results and safety

Results posted to the registry on 4 Nov 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
Warfarin	15,902	15,902
Apixaban	22,336	22,336
Dabigatran	6,925	6,925
Rivaroxaban	16,564	16,564
Edoxaban	12,262	12,262

Primary outcome: Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date

Time frame: During the observation period of approximately 7 years. Number. Unit: Events Per 100 Participant-Years

Measure	Warfarin n = 15902	Apixaban n = 22336	Dabigatran n = 6925	Rivaroxaban n = 16564	Edoxaban n = 12262
Value	3.2	1.67	2.08	1.79	2

Warfarin vs Apixaban: Hazard Ratio (HR): 0.65 (95% CI 0.558 to 0.766), p <0.0001, Cox proportional hazards model
Warfarin vs Dabigatran: Hazard Ratio (HR): 0.79 (95% CI 0.642 to 0.977), p = 0.0291, Cox proportional hazards model
Warfarin vs Rivaroxaban: Hazard Ratio (HR): 0.71 (95% CI 0.592 to 0.842), p = 0.0001, Cox proportional hazards model

Population analysed: OACs treatment-naive participants diagnosed with NVAF, initiating any OACs treatment were included in study. Analysis performed using IPTW method to balance participant characteristics among reporting groups. IPTW method created weighted pseudo-datasets which were used in analysis of outcome measure and are reported in the "units analyzed" field.

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

Time frame: During the observation period of approximately 7 years. Number. Unit: Events Per 100 Participant-Years

Measure	Warfarin n = 15902	Apixaban n = 22336	Dabigatran n = 6925	Rivaroxaban n = 16564	Edoxaban n = 12262
Value	3.13	1.79	1.72	1.82	1.91

Warfarin vs Apixaban: Hazard Ratio (HR): 0.72 (95% CI 0.614 to 0.843), p <0.0001, Cox proportional hazards model
Warfarin vs Dabigatran: Hazard Ratio (HR): 0.66 (95% CI 0.529 to 0.825), p = 0.0003, Cox proportional hazards model
Warfarin vs Rivaroxaban: Hazard Ratio (HR): 0.74 (95% CI 0.618 to 0.879), p = 0.0007, Cox proportional hazards model

Primary outcome: Event Rate Per 100 Participant-Years For First Occurrence of Any Bleeding Event After Index Date

Time frame: During the observation period of approximately 7 years. Number. Unit: Events Per 100 Participant-Years

Measure	Warfarin n = 15902	Apixaban n = 22336	Dabigatran n = 6925	Rivaroxaban n = 16564	Edoxaban n = 12262
Value	22.11	15.97	15.9	16.07	20.34

Warfarin vs Apixaban: Hazard Ratio (HR): 0.93 (95% CI 0.872 to 0.984), p = 0.0127, Cox proportional hazards model
Warfarin vs Dabigatran: Hazard Ratio (HR): 0.96 (95% CI 0.881 to 1.039), p = 0.2893, Cox proportional hazards model
Warfarin vs Rivaroxaban: Hazard Ratio (HR): 0.94 (95% CI 0.881 to 1.004), p = 0.0640, Cox proportional hazards model

7 secondary outcomes are 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
Edoxaban	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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 Non-valvular Atrial Fibrillation, run by Pfizer at 1 site in Japan.

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 5 inclusion and 3 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 4 Nov 2019. 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 Japan. 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 4 Nov 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?

Event Rate Per 100 Participant-Years For First Occurrence of Stroke and Systemic Embolism Events After Index Date (time frame: During the observation period of approximately 7 years). The study lists 3 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 NCT03570047.

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 4 Nov 2019.