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Atrial FibrillationPhase 4ARTESiANCT01938248

Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation

A Phase 4 study testing Apixaban and aspirin in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 130 sites in 13 countries.

Completed

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

Official record
Search all trials

Trial summary

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Atrial Fibrillation, Stroke
What is being tested?
Apixaban and aspirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,012 participants
Where
130 sitesin 13 countries
Study dates
May 2015to 3 Nov 2023
Phase
Phase 4
Are there results?
None posted in the registry

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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF
  • At least one episode of SCAF ≥ 6 minutes in duration but no single episode > 24 hours in duration at any time prior to enrollment. Any atrial high rate episode with average > 175 beats/min will be considered as SCAF. No distinction will be made between atrial fibrillation and atrial flutter. SCAF requires electrogram confirmation (at least one episode) unless ≥ 6 hours in duration.
  • Age ≥ 55 years
  • Risk Factor(s) for Stroke:
  • Previous stroke, TIA or systemic arterial embolism OR Age at least 75 OR Age 65-74 with at least 2 other risk factors OR Age 55-64 with at least 3 other risk factors
  • Other risk factors are:
Show all 11Show fewer
  • hypertension
  • CHF
  • diabetes
  • vascular disease (i.e. CAD, PAD or Aortic Plaque)
  • female

Who cannot join

  • Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting ≥ 6 minutes, with or without clinical symptoms
  • Mechanical valve prosthesis, deep vein thrombosis, recent pulmonary embolism or other condition requiring treatment with an anticoagulant
  • Contra-indication to apixaban or aspirin:
  • Allergy to aspirin or apixaban
  • Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with either a serum creatinine > 2.5 mg/dL [221 µmol/L] or a calculated creatinine clearance < 25 ml/min is excluded)
  • Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, platelet count < 50,000/mm3 or hemoglobin < 10 g/dL, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
Show all 16Show fewer
  • Moderate to severe hepatic impairment
  • Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors)
  • Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of CYP 3A4 or P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
  • Ongoing need for strong dual inducers of CYP 3A4 or P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
  • Received an investigational drug in the past 30 days
  • Participants considered by the investigator to be unsuitable for the study for any of the following reasons:
  • Not agreeable for treatment with either aspirin or apixaban or anticipated to have poor compliance on study drug treatment
  • Unwilling to attend study follow-up visits
  • Life expectancy less than the expected duration of the trial2 years due to concomitant disease
  • Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sterilization, hormonal contraceptives, intrauterine device, barrier methods or abstinence)

Trial locations and contacts

130 sites in 13 countries.

130 sites in 13 countries

Canada24 sites

  • University of Calgary Foothills Hospital

    Calgary, Alberta, T2N 2T9

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Grey Nuns Hospital

    Edmonton, Alberta, T6L 5X8

  • Health Sciences North

    Greater Sudbury, Ontario, P3E 5J1

  • Capital District Health Authority

    Halifax, Nova Scotia

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • St. Mary's General Hospital

    Kitchener, Ontario, N2M 1B2

  • Institute Universitaire de Cardiologie and de Pneumonologie

    Laval, Quebec

  • London Health Sciences Centre

    London, Ontario

  • McGill University Health Centre

    Montreal, Quebec, H3G 1A4

  • CHUM - Hotel Dieu

    Montreal, Quebec

  • Hopital Sacre-Coeur de Montreal

    Montreal, Quebec

  • Montreal Heart Institute

    Montreal, Quebec

  • Southlake Regional Health Centre

    Newmarket, Ontario

  • Oakville Cardiologists

    Oakville, Ontario

  • University of Ottawa Heart Institute

    Ottawa, Ontario

  • CHUS - Sherbrooke

    Sherbrooke, Quebec

  • St. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Hospital

    Toronto, Ontario

  • Ciusss McQ

    Trois-Rivières, Quebec, G8Z 3R9

  • Heart Rhythm Research Office - St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7

  • Victoria Cardiac Arrhythmia Trials, Inc.

    Victoria, British Columbia, V8T 1Z4

  • St. Boniface Hospital

    Winnepeg, Manitoba, R2H 2A6

Other trials in Canada

United States23 sites

  • St. Peter's Health Partners Medical Association, PC

    Albany, New York, 12205

  • Aurora Denver Cardiology Associates

    Aurora, Colorado, 80012

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • The Cooper Health System

    Camden, New Jersey, 08103

  • Carolinas Healthcare System

    Charlotte, North Carolina, 28203

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Missouri Health System

    Columbia, Missouri, 65212

  • Virginia Heart

    Falls Church, Virginia, 22042

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Pennsylvania State University

    Hershey, Pennsylvania, 17033

  • Glacier View Cardiology

    Kalispell, Montana, 59901

  • Research Institute of LG Health / Penn Medicine

    Lancaster, Pennsylvania, 17602

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Cardiovascular Associates of Marin and San Francisco Medical

    Larkspur, California, 94939

  • St. Vincent Heart Clinic

    Little Rock, Arkansas, 72205

  • Cardiovascular Associates of Mesa, PC

    Mesa, Arizona, 85206

  • Naples Interventional Cardiac Electrophysiology

    Naples, Florida, 34102

  • One Health Cardiology, Owensboro Health, Inc.

    Owensboro, Kentucky, 42304

  • Langhorne Cardiology Consultants, Inc.

    Pensacola, Florida, 32501

  • WakeMed

    Raleigh, North Carolina, 27610

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Netherlands15 sites

  • BovenIJ Ziekenhuis

    Amsterdam, 1034 CS

  • Hospital Rijnstate

    Arnhem, 6815 AD

  • Amphia Hospital Breda

    Breda, North Brabant, 4818 CK

  • Deventer Hospital, Cardiology Research

    Deventer, 7416 SE

  • Hospital Gelderse Vallei

    Ede, 6721 JT

  • Treant Hospital Department Cardiology

    Emmen, 7824 AA

  • Admiraal de Ruyter Ziekenhuis

    Goes, 4462 RA

  • Ziekenhuis Tjongerschans

    Heerenveen, Provincie Friesland, 8441 PW

  • Atrium Orbis Heerlen

    Heerlen, Limburg, 6419 PC

  • Treant Hospital - Bethseda, Hoogeveen

    Hoogeveen, 7909 AA

  • Bravis Ziekenhuis, locatie Roosendaal

    Roosendaal, 4708 AE

  • Ikazia Ziekenhuis

    Rotterdam, South Holland, 3083 AN

  • (ETZ) Elisabeth Tweesteden Hospital

    Tilburg, 5022 GC

  • Máxima Medisch Centrum

    Veldhoven, 5504 DB

  • Gelre Ziekenhuis

    Zutphen, Gelderland, 7207 AE

Other trials in Netherlands

Spain13 sites

  • Complexo Hospitalario Universitario A Coruna

    A Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Del Mar

    Barcelona, 8003

  • Hospital Juan Ramon Jimenez

    Huelva, 21005

  • Rafael Mendez Universitary Hospital

    Lorca, Murcia, 30800

  • Hospital Clinico San Carlos, Unidad De Arritmias

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Agencia Sanitaria Costa del Sol- Hospital Costa del Sol

    Marbella, 29603

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Clinico Santiago de Compostela

    Santiago de Composte, A Coruna, 15706

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

Other trials in Spain

Belgium10 sites

  • Onze Lieve Vrouw Ziekenhuis

    Aalst, 9300

  • Vivalia CSL St. Joseph

    Arlon, 6700

  • Clinique Saint Jean-Brussels

    Brussels, 1000

  • Grand Hopital de Charleroi

    Gilly, 6060

  • AZ Groeninge

    Kortrijk, 8500

  • University Hospitals Leuven

    Leuven, 3000

  • CHC Saint Joseph

    Liège, 4000

  • CHR de la Citadelle

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

  • CHU Dinant-Godinne

    Yvoir, 5530

Other trials in Belgium

Italy10 sites

  • AOU Ospedali Riuniti

    Ancona, 60126

  • Ospedale Maggiore, Cardiologia Dept.

    Bologna, 40133

  • S.Orsola-Malpighi

    Bologna, 40138

  • Bolzano Regional Hospital, Dept of Cardiology

    Bolzano, 39100

  • Azienda Ospedaliero-Univeritaria Di Modena-Policlinico

    Modena, 41124

  • Hospital Santa Maria Della Pieta

    Nola, Napoli, 80035

  • Ospedale G.B. Grassi

    Rome, 00122

  • Ospedale Sant'Anna

    San Fermo Della Batt, Como, 22020

  • University and Hospital of Trieste

    Trieste, 34129

  • Cardiologia-A.O. Desio e Vimercate - Presisio di Vimercat

    Vimercate, Monza Brianza MB, 20871

Other trials in Italy

United Kingdom9 sites

  • Hampshire Hospitals (NHS Foundation Trust)

    Basingstoke, Hampshire, RG24 9NA

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, FY3 8NR

  • Dorset County Hospital NHS Foundation Trust

    Dorchester, Dorset, DT12JY

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Royal Alexandra Hospital

    Paisley, Renfrewshire, PA29PN

  • Portsmouth Hospitals NHS Trust

    Portsmouth, Hampshire, PO6 3LY

  • Shrewsbury & Telford Hospital NHS

    Shropshire, West Midlands, TF1 6TF

Other trials in United Kingdom

Germany8 sites

  • MVZ am Kuchwald GmbH

    Chemnitz, Saxony, 09113

  • Zentrum fur klinische Prufungen in der Facharztzentrum Dresd

    Dresden, Saxony, 01099

  • Johann Wolfgang Goethe University Hospital Frankfurt

    Frankfurt am Main, Hesse, 60590

  • University Medicine Gottingen

    Göttingen, 37075

  • Asklepios Klinik Barmbek

    Hamburg, 22291

  • Universitatsklinikum des Saarlandes

    Homburg/Saar, Saarland, 66421

  • Katholisches Klinikum Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitaetsklinikum Tuebingen, Kardiologie

    Tübingen, 72076

Other trials in Germany

Denmark7 sites

  • Sygehus Sonderjylland

    Aabenraa, 6200

  • Aalborg University Hospital, Dept of Cardiology

    Aalborg, 9000

  • Aarhus Unniversity Hospital, Skejby

    Aarhus, DK-8200

  • Gentofte Hospital

    Hellerup, 2900

  • Hilleroed Hospital

    Hilleroed, North Zealand, 3400

  • Odense University Hospital

    Odense, 5000

  • Hjertemedicinsk Forskning, RH Viborg, HEM

    Viborg, 8800

Other trials in Denmark

Switzerland5 sites

  • University Hospital Basel

    Basel, Canton of Basel-City, 4031

  • Hopital Fribourgeois, site de Fribourg

    Fribourg, 1708

  • University Hospital of Geneva

    Geneva, 1211

  • CHUV

    Lausanne, Canton of Vaud, 1011

  • Kantonsspital St Gallen

    Sankt Gallen, Canton of St. Gallen, 9007

Other trials in Switzerland

Hungary3 sites

  • Allami Szivkorhaz Balatonfured

    Balatonfüred, Veszprém megye, 8230

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134

  • Semmelweis University

    Budapest, H-1122

Other trials in Hungary

Norway2 sites

  • Barum Hospital, Vestre Viken

    Drammen, Buskerud, 3004

  • Oslo University Hospital - Ulleval

    Oslo, 0450

Other trials in Norway

Czechia1 site

  • IKEM Institute for Clinical and Experimental Medicine

    Prague, 14021

Other trials in Czechia

About this study

This study aims to determine if treatment with apixaban, compared with aspirin, will reduce the risk of ischemic stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation and additional risk factors for stroke.

Read the detailed description

Device-detected sub-clinical atrial fibrillation (SCAF) is a new disorder that has been recognized since the availability of implantable devices capable of long term continuous heart rhythm monitoring. It is characterized by one or more runs of rapid atrial arrhythmia detected by the device without symptoms and without any clinical atrial fibrillation (AF) detected by the usual methods, (i.e. electrocardiogram, Holter monitor, etc.). In the ASSERT trial, SCAF was detected by a pacemaker or implantable cardioverter defibrillator (ICD) in nearly 40% of patients during 2 and a half years of follow up. The presence of SCAF increased stroke risk by 2.5-fold (1). The risk of stroke or systemic embolism among patients with SCAF and a CHADS2 score ≥ 4 was 2.75% per year. Oral anticoagulation is effective and safe for stroke prevention in patients with clinical atrial fibrillation, but it is unknown if the same risk benefit ratio exists for anticoagulation therapy in patients with SCAF (2;3). SCAF differs from clinical AF in being of shorter duration, being asymptomatic, and often have a more regular rhythm in the right atrium where it is typically detected. Data ASSERT suggest that the increase in stroke risk with SCAF may be less than the increase with clinical AF. Therefore opinion leaders have written that the role of oral anticoagulation for the treatment of SCAF is uncertain and that randomized trials of anticoagulation are needed (4;5). Recent surveys of pacemaker clinic practice indicate that only 25% of patients with SCAF are treated with oral anticoagulation (6;7). Thus there is clinical equipoise for a trial of oral anticoagulation compared to aspirin in higher risk patients with SCAF.

Apixaban is a Factor Xa inhibitor that is an effective and safe anticoagulant. It has been shown to have an excellent risk benefit profile for stroke prevention in clinical AF (14, 15). It is highly suitable to test if oral anticoagulation therapy will reduce the risk of stroke or systemic embolism in SCAF.

Patients will be randomized double-blind to receive apixaban or aspirin. Apixaban dose will be 5 mg twice daily (2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L). Those assigned to aspirin will receive a dose of 81 mg daily. The study will be event driven and will continue until 248 patients have experienced a primary outcome event.

Being tested
Apixaban, aspirin
Keywords
Pacemaker, Artificial, Defibrillators, Implantable, Atrial Fibrillation, Stroke Risk
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

    Also called Eliquis

    apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)

  • aspirinDrug

    Also called ASA, acetylsalicylic acid

    aspirin 81 mg once daily

Study groups in NCT01938248
Study groupRoleWhat they receive
ControlActive comparatorAspirin 81 mg once daily
Receives: Drug: aspirin
InterventionExperimentalApixaban, 5 mg twice daily (or 2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
Receives: Drug: Apixaban

What is being measured

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

  1. Composite of ischemic stroke and systemic embolism

    Definition of stroke:

    1. Rapid onset* of a focal/global neurological deficit
    2. Duration of a focal/global neurological deficit ≥ 24 hours OR the neurological deficit results in death OR the neurological deficit is supported by clear evidence of cerebral infarction on diffusion-weighted MRI imaging.
    3. No other readily identifiable non-stroke cause for the clinical presentation
    4. Confirmation of the diagnosis by specialist evaluation or brain imaging procedure

    Definition of Systemic Embolism:

    Clinical signs and symptoms consistent with embolic arterial occlusion plus at least one of the following objective findings of arterial embolism:

    • Surgical report indicating evidence of arterial embolism
    • Pathological specimens related to embolism removal
    • Imaging evidence consistent with arterial embolism
    • Autopsy reports

    Measured: event driven, duration of follow-up - mean follow-up time anticipated: 3 years

  2. Major Bleed

    The main safety outcome will be the occurrence of clinically overt major bleeding as defined by the ISTH criteria:

    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
    3. Bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells.

    Measured: duration of follow-up

Secondary outcomes (6)

  1. Ischemic Stroke

    Measured: Duration of Follow-up

  2. Myocardial Infarction

    MI definition:

    1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CKMB) of biochemical markers of myocardial necrosis with at least one of: a) ischemic symptoms; b) development of pathological Q-waves on the ECG; c) ECG changes indicative of ischemia; d) Coronary artery intervention OR
    2. Pathological findings of an acute myocardial infarction

    Measured: Duration of follow-up

  3. Cardiovascular Death

    Measured: Duration of follow-up

  4. All-cause Death

    Measured: Duration of follow-up

  5. Composite of stroke, MI, SE and death

    Composite of stroke, myocardial infarction, systemic embolism and all-cause death

    Measured: Duration of follow-up

  6. Composite of stroke, MI, SE, death and major bleeding

    Composite of stroke, myocardial infarction, systemic embolism, all-cause death and major bleeding

    Measured: Duration of follow-up

Timeline

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

  1. First posted10 Sep 2013 (estimated)
  2. Study startMay 2015
  3. Primary completion27 Oct 2023
  4. Study completion3 Nov 2023

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,012 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938248
Sponsor's protocol ID
ARTESiA
Other IDs
2014-001397-33, 2014
Acronym
ARTESiA
Status last verified
Nov 2023
First submitted
4 Sep 2013
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Siegal DM, Sticherling C, Healey JS, McIntyre WF, Christensen LS, Parkash R, Vanassche T, Conen D, Gold M, Granger CB, Nielsen JC, Carrier M, Wojdyla DM, Erath JW, Rivard L, Kutyifa V, Wright DJ, Lopes RD. Major Bleeding With Apixaban vs Aspirin: A Subanalysis of the ARTESiA Randomized Clinical Trial. JAMA Cardiol. 2025 Dec 1;10(12):1305-1314. doi: 10.1001/jamacardio.2025.4151.

    PubMed 41222953

  • Shoamanesh A, Field TS, Coutts SB, Sharma M, Gladstone D, Hart RG, Boriani G, Wright DJ, Sticherling C, Birnie DH, Gold MR, Erath JW, Kutyifa V, Mian R, Benz AP, Granger CB, McIntyre WF, Connolly SJ, Nielsen JC, Alings M, Rivard L, Lopes RD, Healey JS; ARTESiA study investigators. Apixaban versus aspirin for stroke prevention in people with subclinical atrial fibrillation and a history of stroke or transient ischaemic attack: subgroup analysis of the ARTESiA randomised controlled trial. Lancet Neurol. 2025 Feb;24(2):140-151. doi: 10.1016/S1474-4422(24)00475-7.

    PubMed 39862882

  • McIntyre WF, Benz AP, Healey JS, Connolly SJ, Yang M, Lee SF, Field TS, Alings M, Benezet-Mazuecos J, Boriani G, Nielsen JC, Gold MR, Pergolini F, Glotzer TV, Granger CB, Lopes RD. Risk of Stroke or Systemic Embolism According to Baseline Frequency and Duration of Subclinical Atrial Fibrillation: Insights From the ARTESiA Trial. Circulation. 2024 Nov 26;150(22):1747-1755. doi: 10.1161/CIRCULATIONAHA.124.069903. Epub 2024 Sep 4.

    PubMed 39229707

  • Lopes RD, Granger CB, Wojdyla DM, McIntyre WF, Alings M, Mani T, Ramasundarahettige C, Rivard L, Atar D, Birnie DH, Boriani G, Amit G, Leong-Sit P, Rinne C, Duray GZ, Gold MR, Hohnloser SH, Kutyifa V, Benezet-Mazuecos J, Cosedis Nielsen J, Sticherling C, Benz AP, Linde C, Kautzner J, Mabo P, Mairesse GH, Connolly SJ, Healey JS. Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA. J Am Coll Cardiol. 2024 Jul 23;84(4):354-364. doi: 10.1016/j.jacc.2024.05.002. Epub 2024 May 19.

    PubMed 39019530

  • Healey JS, Lopes RD, Granger CB, Alings M, Rivard L, McIntyre WF, Atar D, Birnie DH, Boriani G, Camm AJ, Conen D, Erath JW, Gold MR, Hohnloser SH, Ip J, Kautzner J, Kutyifa V, Linde C, Mabo P, Mairesse G, Benezet Mazuecos J, Cosedis Nielsen J, Philippon F, Proietti M, Sticherling C, Wong JA, Wright DJ, Zarraga IG, Coutts SB, Kaplan A, Pombo M, Ayala-Paredes F, Xu L, Simek K, Nevills S, Mian R, Connolly SJ; ARTESIA Investigators. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation. N Engl J Med. 2024 Jan 11;390(2):107-117. doi: 10.1056/NEJMoa2310234. Epub 2023 Nov 12.

    PubMed 37952132

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban and aspirin in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 130 sites in 13 countries.

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 11 inclusion and 16 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 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in Canada, United States, Netherlands, Spain, Belgium and 8 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite of ischemic stroke and systemic embolism (time frame: event driven, duration of follow-up - mean follow-up time anticipated: 3 years). The study lists 2 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 NCT01938248, which also lists 5 linked publications.

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 15 Nov 2023.

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