Atrial FibrillationPhase 3ARISTANCT03839355

Trial of Apixaban vs Warfarin in Reducing Rate of Cognitive Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Patients With Atrial Fibrillation

A Phase 3 study testing Apixaban and Warfarin in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 60 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Apixaban and Warfarin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2018to 15 Dec 2020
Phase: Phase 3
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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Non-valvular Atrial Fibrillation
CHA2DS2-VASc Score > or = to 2
Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month
Candidate for oral anticoagulation as assessed by a treating physician

Who cannot join

Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
Active Bleeding
Prior treatment with Apixaban >1 month
Recent stroke within 7 days
Dementia
Implanted devices not compatible with MRI/any cardiac implanted device

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Claustrophobia
Active alcohol/drug abuse
Life expectancy < 1 year
Taking asprin with >100mg doses
Known hypersensitivity to warfarin or Apixaban
Severe renal insufficiency
Prior severe bleeding (Intracranial bleeding (subdural, subarachnoid, intraparenchymal bleeding),GI bleed requiring transfusion,Bleeding from other sites requiring transfusion)
Psychosocial reasons that make study participation impractical
Currently enrolled in another IND or IDE trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints
Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or that could impact the scientific integrity of the study.
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
Current or expected systemic treatment with strong dual inhibitors of CYP3A4 and P-gp (Any one of rifampin, carbamazepine, phenytoin, St. John's Wort, ketoconazole, itraconazole, ritonavir, clarithromycin)
Need for dual anti-platelet therapy with aspirin and another agent such as thienopyridine

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2

The investigators' central hypothesis is that in patients with atrial fibrillation, anticoagulation with Apixaban reduces the rate of decline in cognitive function, when compared to Warfarin. The investigators also hypothesize that Apixaban reduces cognitive decline by reducing the rate of new cerebral infarction and cerebral microbleeds detected by cerebral MRI compared to warfarin.

Conditions: Atrial Fibrillation
Being tested: Apixaban, Warfarin
Keywords: Apixaban, Warfarin
Medical subject headings: Atrial Fibrillation

What participants receive

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

ApixabanDrug
Also called Eliquis
Dosage either 5mg or 2.5mg for 2 years
WarfarinDrug
Also called Coumadin
Dosage assessed by your treating physician for 2 years

Study groups in NCT03839355
Study group	Role	What they receive
Eliquis	Active comparator	Not described Receives: Drug: Apixaban
Warfarin	Active comparator	Not described Receives: Drug: Warfarin

What is being measured

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

Standardized Neurocognitive Function Score
Assess the change in cognitive function using standardized neurocognitive assessment.
Measured: Baseline, Year 1, Year 2
MRI Evidence of Silent Cerebral Infarct
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.
Measured: Baseline, Year 2
MRI Evidence of New Cerebral Micro-bleeds
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds
Measured: Baseline, Year 2

Timeline

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

19 Dec 201815 Dec 2020

First posted15 Feb 2019
Study start19 Dec 2018
Primary completion15 Dec 2020
Study completion15 Dec 2020

Why it stopped: Study terminated due to slower than anticipated enrollment.

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 Mayo ClinicThe 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: Interventional
Phase: Phase 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03839355
Sponsor's protocol ID: 17-010544
Acronym: ARISTA
Status last verified: Feb 2021
First submitted: 11 Feb 2019
Last updated: 16 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial of Apixaban vs Dose Adjusted Warfarin in Reducing Rate of Cognitive Function Decline, Silent Cerebral Infarcts and Cerebral Microbleeds in Non-valvular Atrial Fibrillation Patients With CHA2DS2-VaSc Score = 2
ClinicalTrials.gov ID: NCT03839355
Acronym / sponsor ID: ARISTA / 17-010544
Conditions: Atrial Fibrillation
Keywords: Apixaban, Warfarin
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated due to slower than anticipated enrollment.
Enrolment: 34 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: Pfizer, Bristol-Myers Squibb
Study start: 19 Dec 2018 (actual)
Primary completion: 15 Dec 2020 (actual)
Study completion: 15 Dec 2020 (actual)
First posted: 15 Feb 2019 (actual)
Results: Posted 16 Mar 2021

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Eliquis	Active comparator	Drug: Apixaban
Warfarin	Active comparator	Drug: Warfarin

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Non-valvular Atrial Fibrillation
CHA2DS2-VASc Score > or = to 2
Never been treated with Apixaban (Eliquis) or prior treatment of < 1 month
Candidate for oral anticoagulation as assessed by a treating physician

Key exclusion criteria (20 listed)

Valvular Atrial Fibrillation (Rheumatic valve disease,Moderate or greater mitral stenosis,Mechanical cardiac valve)
Active Bleeding
Prior treatment with Apixaban >1 month
Recent stroke within 7 days
Dementia

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

Interventions

Intervention	Type	Arms
ApixabanAlso: EliquisDosage either 5mg or 2.5mg for 2 years	Drug	Eliquis
WarfarinAlso: CoumadinDosage assessed by your treating physician for 2 years	Drug	Warfarin

Primary outcome

Standardized Neurocognitive Function Score
Time frame: Baseline, Year 1, Year 2
Assess the change in cognitive function using standardized neurocognitive assessment.
MRI Evidence of Silent Cerebral Infarct
Time frame: Baseline, Year 2
Magnetic Resonance Imagining of the brain to assess the development of new silent cerebral infarcts.
MRI Evidence of New Cerebral Micro-bleeds
Time frame: Baseline, Year 2
Magnetic Resonance Imagining of the brain to assess the development of new cerebral micro-bleeds

Results and safety

Results posted to the registry on 16 Mar 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eliquis	18	17
Warfarin	16	16

Primary outcome: Standardized Neurocognitive Function Score

Time frame: Baseline, Year 1, Year 2

Population analysed: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.

Primary outcome: MRI Evidence of Silent Cerebral Infarct

Time frame: Baseline, Year 2

Population analysed: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.

Primary outcome: MRI Evidence of New Cerebral Micro-bleeds

Time frame: Baseline, Year 2

Population analysed: Study terminated due to slower than anticipated enrollment. Data was not collected or analyzed.

Adverse events

Time frame: Adverse events were collected from baseline to end of treatment for approximately 24 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eliquis	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Warfarin	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.

Related trials for Atrial Fibrillation

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

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Malini Madhavan principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban and Warfarin in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 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: stopped early, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standardized Neurocognitive Function Score (time frame: Baseline, Year 1, Year 2). 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 NCT03839355.

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 16 Mar 2021.