AzTrials
AzTrials

StrokePhase 3ARCADIANCT03192215

AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

A Phase 3 study testing Apixaban and Aspirin in people with Stroke, run by Columbia University at 177 sites in 2 countries.

Terminated

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

Official record
Search all trials

Trial summary

Objectives Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Stroke
What is being tested?
Apixaban and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,015 participants
Where
177 sitesin 2 countries
Study dates
19 Jan 2018to 17 Apr 2023
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 45 years.
  • Clinical diagnosis of ischemic stroke + brain imaging to rule out hemorrhagic stroke.
  • Modified Rankin Scale (MRS) score ≤ 4.
  • Ability to be randomized within 3 to 180 days after stroke onset.
  • ESUS, defined as all of the following:
  • Stroke detected by CT or MRI that is not lacunar. Lacunar is defined as a subcortical (this includes pons and midbrain) infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images/<1.5 cm on T2 weighted MR images. The following are not considered lacunes: multiple simultaneous small deep infarcts, lateral medullary infarcts, and cerebellar infarcts. Patients with a clinical lacunar stroke syndrome and no infarct on imaging are excluded.
Show all 9Show fewer
  • Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia. Patients must undergo vascular imaging of the extracranial and intracranial vessels using either catheter angiography, CT angiogram (CTA), MR angiogram (MRA), or ultrasound, as considered appropriate by the treating physician and local principal investigator.
  • No major-risk cardioembolic source of embolism, including intracardiac thrombus, mechanical prosthetic cardiac valve, atrial myxoma or other cardiac tumors, moderate or severe mitral stenosis, myocardial infarction within the last 4 weeks, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis). Patent foramen ovale is not an exclusion. All patients must undergo electrocardiogram, transthoracic or transesophageal echocardiography (TTE or TEE) and at least 24 hours of cardiac rhythm monitoring (Holter monitor or telemetry or equivalent). Additional cardiac imaging, such as cardiac MRI, or cardiac CT will be performed at the discretion of the local treating physician and principal investigator. Additional cardiac rhythm monitoring, such as monitored cardiac outpatient telemetry (MCOT) or an implanted cardiac monitor, will be at the discretion of the treating physician and local principal investigator.
  • No other specific cause of stroke identified, such as arteritis, dissection, migraine, vasospasm, drug abuse, or hypercoagulability. Special testing, such as toxicological screens, serological testing for syphilis, and tests for hypercoagulability, will be performed at the discretion of the treating physician and local principal investigator.

Who cannot join

  • History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
  • Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
  • Need for antiplatelet agent, such as aspirin or clopidogrel
  • History of spontaneous intracranial hemorrhage.
  • Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion.
  • Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
Show all 19Show fewer
  • Clinically significant bleeding diathesis.
  • Unresolved anemia (hemoglobin <9 g/dL) or thrombocytopenia (<100 x 10E9/L).
  • Clinically significant gastrointestinal bleeding within the past year (e.g., not due to external hemorrhoids).
  • At risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control, which includes an oral contraceptive, two methods of barrier birth control such as condom with or without spermicidal lubricant + diaphragm, or abstinence.
  • Known allergy or intolerance to aspirin or apixaban.
  • Concomitant participation in another clinical trial involving a drug or acute stroke intervention.
  • Considered by the investigator to have a condition that precludes follow-up or safe participation in the trial.
  • Inability of either participant or surrogate to provide written, informed consent for trial participation.
  • To be eligible for randomization, consented participants must meet criteria for atrial cardiopathy in addition to the inclusion/exclusion criteria above.
  • Atrial cardiopathy is defined as ≥1 of the following:
  • PTFV1 >5,000 μV*ms on 12-lead ECG (ECG criterion).
  • Serum NT-proBNP >250 pg/mL (NT-proBNP criterion).
  • Left atrial diameter index ≥3 cm/m2 on echocardiogram (i.e., severe left atrial enlargement) (ECHO criterion)

Trial locations and contacts

177 sites in 2 countries.

177 sites in 2 countries

United States165 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Univ. New Mexico

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • UPMC Altoona

    Altoona, Pennsylvania, 16601

  • University of Michigan University Hospital

    Ann Arbor, Michigan, 48109

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30303

  • Grady Memorial

    Atlanta, Georgia, 30303

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Alabama

    Birmingham, Alabama, 35233

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical

    Boston, Massachusetts, 02215

  • Brigham & Womens Hospital

    Boston, Massachusetts, 20115

  • St. Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Kings County Hospital

    Brooklyn, New York, 11203

  • New York Presbyterian - Brooklyn Methodist Hospital

    Brooklyn, New York, 11215-3609

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • NYU Langone Hospital - Brooklyn

    Brooklyn, New York, 11220

  • Mount Sinai Beth Israel Brooklyn

    Brooklyn, New York, 11234

  • Buffalo General Medical Center

    Buffalo, New York, 14203

  • Lahey Hospital & Medical Center

    Burlington, Massachusetts, 01805

  • Cooper University Hospital,

    Camden, New Jersey, 08103

  • Mercy San Juan Medical Center (Dignity Health)

    Carmichael, California, 95608

  • Eden Medical Center

    Castro Valley, California, 94546

  • Chandler Regional Medical Center Chandler, AZ

    Chandler, Arizona, 85224

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • UVA Medical Center

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • Louis Stokes VA Medical Center

    Cleveland, Ohio, 44106

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Prisma Health Richland Hospital (formerly Palmetto Health)

    Columbia, South Carolina, 29203

  • OSU Wexner

    Columbus, Ohio, 43210

  • Ohio Health Riverside - Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Miami Valley Hospita

    Dayton, Ohio, 45409

  • Multi-Specialty - Methodist Plaza/Unity Point

    Des Moines, Iowa, 50309

  • Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58122

  • McLaren Flint

    Flint, Michigan, 48532

  • Fountain Valley Regional Hospital and Medical Center

    Fountain Valley, California, 92708

  • Community Regional Medical Center

    Fresno, California, 93721

  • UF Health Shands

    Gainesville, Florida, 32610

  • St. Mary's Medical Center

    Grand Junction, Colorado, 81501

  • Mercy Health St. Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27405

  • Prisma Health Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Valley Bapist

    Harlingen, Texas, 78550

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Baylor College College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • University of Iowa

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • UCSD Health La Jolla

    La Jolla, California, 92037

  • Sharp Grossmont Hospital

    La Mesa, California, 92123

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Los Alamitos Medical Center

    Los Alamitos, California, 90720

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Keck Hospital Of USC

    Los Angeles, California, 90033

  • Los Angeles County- USC Medical Center

    Los Angeles, California, 90033

  • VA Greater Los Angeles - West LA VA Medical Center

    Los Angeles, California, 90073

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • University of Louisville Hospital

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • North Shore University Hospital

    Manhasset, New York, 11042

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Jackson Memorial

    Miami, Florida, 33136

  • Univ. Miami Hospital

    Miami, Florida, 33136

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County

    Minneapolis, Minnesota, 55415

  • Univ. of Minnesota

    Minneapolis, Minnesota, 55455

  • University of South Alabama University Hospital

    Mobile, Alabama, 36604

  • WVU Healthcare Ruby Memorial

    Morgantown, West Virginia, 26506-9180

  • McLaren Macomb, Mount Clemens, MI

    Mount Clemens, Michigan, 48043

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt

    Nashville, Tennessee, 37212

  • Robert Wood Johnson

    New Brunswick, New Jersey, 08901

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • NYU Langone

    New York, New York, 10003

  • Mount Sinai West

    New York, New York, 10019

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Christiana Hospital

    Newark, Delaware, 19718

  • OU Medical Center Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Providence St. Peter Hospital

    Olympia, Washington, 98506

  • CHI Health Immanuel

    Omaha, Nebraska, 68124

  • University of Nebraska

    Omaha, Nebraska, 68198

  • UC Irvine Medical Center

    Orange, California, 92868

  • Capital Health Medical Center Hopewell

    Pennington, New Jersey, 08534

  • OSF St. Francis Medical Center

    Peoria, Illinois, 61637

  • McLaren Northern Michigan

    Petoskey, Michigan, 49770

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Legacy Emanuel

    Portland, Oregon, 97227

  • Oregon Health and Sciences

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Bon Secours St. Mary's Hospital

    Richmond, Virginia, 23226

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Strong Memorial Hospital

    Rochester, New York, 14642

  • Sutter Medical Center

    Sacramento, California, 95816

  • Regions Hospital, St. Paul

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Salinas Valley Memorial Hospital

    Salinas, California, 93901

  • Univ of Utah

    Salt Lake City, Utah, 84132

  • George E Whalen VA

    Salt Lake City, Utah, 84148

  • Univ of Texas Health Science Center San Antonio

    San Antonio, Texas, 78229

  • Scripps Mercy

    San Diego, California, 91910

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California, 92103

  • Kaiser Permanent San Diego Medical Center

    San Diego, California, 92123

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • San Francisco General

    San Francisco, California, 94110

  • UCSF Medical Center

    San Francisco, California, 94143

  • Good Samaritan

    San Jose, California, 95124

  • Intercoastal Medical Group - Hyde Park

    Sarasota, Florida, 34239

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Puget Sound VA

    Seattle, Washington, 98108

  • Swedish Medical Center - Cherry Hill Campus

    Seattle, Washington, 98122

  • Southern Illinois University Memorial Medical Center

    Springfield, Illinois, 62702

  • St. John's Hospital (Prairie Research)

    Springfield, Illinois, 62769

  • Cox Medical Center South

    Springfield, Missouri, 65807

  • St. Louis University Hospital

    St Louis, Missouri, 63104

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • Tampa General

    Tampa, Florida, 33606

  • Scott & White Memorial Hospital - Temple

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Memorial Hermann The Woodlands Hospital

    The Woodlands, Texas, 77380

  • Mercy St Vincent Medical Center

    Toledo, Ohio, 43608

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85724

  • Med-star Georgetown Univ.

    Washington D.C., District of Columbia, 20007

  • Medstar Washington

    Washington D.C., District of Columbia, 20010

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • U Mass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada12 sites

  • Brandon Regional Health Center

    Brandon, Manitoba, R7A 2B3

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, T2N2T9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3

  • Hamilton General Hospital

    Hamilton, Ontario, L8L2X2

  • Kelowna General Hospital

    Kelowna, British Columbia, V1Y 1T2

  • Kingston General Hospital

    Kingston, Ontario, K7L2V7

  • Neurologic Research Center

    Lethbridge, Alberta, T1J 0N9

  • London Health Sciences Center

    London, Ontario, N6A 5A5

  • Enfant-Jesus Hospital

    Québec, Quebec, G1J 1Z4-65543

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N0W8

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

Objectives

  • Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.
  • Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.
Read the detailed description

ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. Eleven hundred subjects will be recruited over 2.5 years at up to 200 sites in and out of the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 7 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.

Conditions
Stroke
Being tested
Apixaban, Aspirin
Keywords
Atrial Cardiopathy, Cryptogenic stroke, Ischemic stroke, Apixaban, Aspirin
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

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

  • ApixabanDrug

    Also called Eliquis

    5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).

  • AspirinDrug

    Also called Aspirin Tablet

    Aspirin 81 mg by mouth once daily.

Study groups in NCT03192215
Study groupRoleWhat they receive
Active agent: ApixabanExperimentalPatients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Receives: Drug: Apixaban
Active control: AspirinActive comparatorPatients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Receives: Drug: Aspirin

What is being measured

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

  1. Number of Participants With Recurrent Stroke of Any Type

    Participants were monitored for up to 5 years of study participation. This is the number of participants who had recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type).

    Measured: Up to 5 years of study participation.

Secondary outcomes (5)

  1. Number of Participants With Recurrent Ischemic Stroke or Systemic Embolism

    Secondary efficacy outcome A. Participants were monitored for up to 5 years. This is the number of participants who had recurrent ischemic stroke or systemic embolism during the time of observation.

    Measured: Up to 5 years of study participation.

  2. Number of Participants With Recurrent Stroke of Any Type or Death From Any Cause

    Secondary efficacy outcome B. Participants were monitored for up to 5 years. This is the number of participants who had recurrent stroke of any type or death from any cause during the observation time.

    Measured: Up to 5 years of study participation.

  3. Number of Participants With Symptomatic Intracranial Hemorrhage (Including Symptomatic Hemorrhagic Transformation of an Ischemic Stroke)

    Primary safety outcome A. This is the number of participants who had symptomatic intracranial hemorrhage from any cause during the time of observation. Symptomatic intracranial hemorrhage includes symptomatic hemorrhagic transformation of ischemic stroke, which required new symptoms or signs adjudicated as being due to the hemorrhagic transformation or a patient whose initial imaging was judged to include hemorrhagic transformation of an ischemic stroke.

    Measured: Through 30 days after permanent discontinuation of the study drug, a duration of up to 5 years for each participant.

  4. Number of Participants With Major Hemorrhage Other Than Intracranial Hemorrhage.

    This is the number of participants who had major hemorrhage other than intracranial hemorrhage.

    Measured: Through 30 days after permanent discontinuation of the study drug, a duration of up to 5 years for each participant.

  5. Number of Participant Deaths From Any Cause Number of Participants With All-cause Mortality.

    Secondary safety outcome. This is the number of participants who had all-cause mortality during time of observation.

    Measured: Through 30 days after permanent discontinuation of the study drug, a duration of up to 5 years for each participant.

Timeline

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

  1. First posted20 Jun 2017
  2. Study start19 Jan 2018
  3. Primary completion31 Mar 2023
  4. Study completion17 Apr 2023

Why it stopped: The DSMB halted the trial prematurely due to futility without any safety concerns.

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Active treatment will be either apixaban 5 mg or aspirin 81 mg. An adjusted dose of apixaban 2.5 mg will be used for subjects with at least two of the following: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or known serum creatinine greater than or equal to 1.5 mg/dL. There will be six possible study tablets: apixaban 5 mg (regular dose), apixaban 2.5 mg (adjusted dose), apixaban 5 mg placebo, apixaban 2.5 mg placebo, aspirin 81 mg, and aspirin placebo. All subjects will be randomized to receive active treatment with either active apixaban or active aspirin. Study treatments will be supplied in a double-dummy fashion as apixaban 5 mg (2.5 mg for the adjusted dose) or matching placebo, and aspirin 81 mg or matching placebo.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,015 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03192215
Sponsor's protocol ID
AAAR4607
Other IDs
1U01NS095869-01A1
Acronym
ARCADIA
Status last verified
Apr 2025
First submitted
16 Jun 2017
Last updated
9 Apr 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.

Publications

  • Kamel H, Okin PM, Elkind MS, Iadecola C. Atrial Fibrillation and Mechanisms of Stroke: Time for a New Model. Stroke. 2016 Mar;47(3):895-900. doi: 10.1161/STROKEAHA.115.012004. Epub 2016 Jan 19. No abstract available.

    PubMed 26786114

  • Yaghi S, Kamel H, Elkind MS. Potential new uses of non-vitamin K antagonist oral anticoagulants to treat and prevent stroke. Neurology. 2015 Sep 22;85(12):1078-84. doi: 10.1212/WNL.0000000000001817. Epub 2015 Jul 17.

    PubMed 26187229

  • Kamel H, Okin PM, Longstreth WT Jr, Elkind MS, Soliman EZ. Atrial cardiopathy: a broadened concept of left atrial thromboembolism beyond atrial fibrillation. Future Cardiol. 2015 May;11(3):323-31. doi: 10.2217/fca.15.22.

    PubMed 26021638

  • Yaghi S, Moon YP, Mora-McLaughlin C, Willey JZ, Cheung K, Di Tullio MR, Homma S, Kamel H, Sacco RL, Elkind MS. Left atrial enlargement and stroke recurrence: the Northern Manhattan Stroke Study. Stroke. 2015 Jun;46(6):1488-93. doi: 10.1161/STROKEAHA.115.008711. Epub 2015 Apr 23.

    PubMed 25908460

  • Longstreth WT Jr, Kronmal RA, Thompson JL, Christenson RH, Levine SR, Gross R, Brey RL, Buchsbaum R, Elkind MS, Tirschwell DL, Seliger SL, Mohr JP, deFilippi CR. Amino terminal pro-B-type natriuretic peptide, secondary stroke prevention, and choice of antithrombotic therapy. Stroke. 2013 Mar;44(3):714-9. doi: 10.1161/STROKEAHA.112.675942. Epub 2013 Jan 22.

    PubMed 23339958

  • Ridha M, Hailat R, Stanton R, Merkler AE, Elkind MSV, Longstreth WT Jr, Tirschwell DL, Kronmal RA, Hannawi Y, Kamel H, Burke J, Woo D. Hypertension With High-Risk Features in Cryptogenic Stroke: An Exploratory Analysis of the ARCADIA Randomized Clinical Trial. JAMA Neurol. 2026 Jun 1;83(6):573-581. doi: 10.1001/jamaneurol.2026.0855.

    PubMed 42008258

  • Lazar RM, Howard G, Brewer MT, Cassarly C, Pauls Q, Kemp S, Tirschwell DL, Sheth KN, Wintermark M, Kamel H, Longstreth WT Jr, Elkind MSV, Broderick JP, Lansberg MG. Apixaban Versus Aspirin to Reduce Cognitive Decline After Cryptogenic Stroke and Atrial Cardiopathy: ARCADIA-Cognition Study. J Am Heart Assoc. 2025 Sep 16;14(18):e042147. doi: 10.1161/JAHA.125.042147. Epub 2025 Aug 22.

    PubMed 40847528

  • Elias A, Teraoka JT, Soliman EZ, Elkind MSV, Kamel H, Kronmal RA, Longstreth WT Jr, Tirschwell DL, Di Tullio MR, Marcus GM. Premature Atrial Contractions as a Marker of Atrial Cardiopathy: A Revised Analysis of the ARCADIA Randomized Trial. J Cardiovasc Electrophysiol. 2025 Jul;36(7):1487-1493. doi: 10.1111/jce.16629. Epub 2025 Apr 28.

    PubMed 40294164

  • Navi BB, Elkind MSV, Zhang C, Tirschwell DL, Kronmal RA, Elm J, Broderick JP, Gladstone DJ, Beyeler M, Kamel H, Longstreth WT Jr. History of Cancer and Atrial Cardiopathy: A Secondary Analysis of the ARCADIA Clinical Trial. J Am Heart Assoc. 2025 May 6;14(9):e040543. doi: 10.1161/JAHA.124.040543. Epub 2025 Apr 23.

    PubMed 40265582

  • Lansberg MG, Wintermark M, Chen H, Howard G, Cassarly C, Pauls Q, Kemp S, Harris TL, Krishnaiah B, Stanton RJ, Lyerly MJ, Miller BR, Smith EE, Tirschwell DL, Sheth KN, Kamel H, Longstreth WT Jr, Elkind MSV, Broderick JP, Lazar RM. Apixaban to Prevent Covert Infarcts After Cryptogenic Stroke in Patients With Atrial Cardiopathy: A Secondary Analysis of the ARCADIA Randomized Clinical Trial. JAMA Neurol. 2025 Mar 1;82(3):220-227. doi: 10.1001/jamaneurol.2024.4838.

    PubMed 39869342

  • Navi BB, Zhang C, Miller BR, Pawar A, Cushman M, Kasner SE, Tirschwell D, Longstreth WT, Kronmal R, Elm J, Zweifler RM, Tarsia J, Broderick JP, Gladstone DJ, Beyeler M, Kamel H, Elkind MSV, Streib C. Diagnosis of Incident Cancer After Cryptogenic Stroke: An Exploratory Analysis of the ARCADIA Randomized Trial. Neurology. 2024 Nov 26;103(10):e210027. doi: 10.1212/WNL.0000000000210027. Epub 2024 Oct 31.

    PubMed 39481070

  • Navi BB, Zhang C, Miller B, Cushman M, Kasner SE, Elkind MSV, Tirschwell DL, Longstreth WT Jr, Kronmal RA, Beyeler M, Elm J, Zweifler RM, Tarsia J, Cereda CW, Bianco G, Costamagna G, Michel P, Broderick JP, Gladstone DJ, Kamel H, Streib C. Apixaban vs Aspirin in Patients With Cancer and Cryptogenic Stroke: A Post Hoc Analysis of the ARCADIA Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):958-965. doi: 10.1001/jamaneurol.2024.2404.

    PubMed 39133474

  • Kamel H, Longstreth WT Jr, Tirschwell DL, Kronmal RA, Marshall RS, Broderick JP, Aragon Garcia R, Plummer P, Sabagha N, Pauls Q, Cassarly C, Dillon CR, Di Tullio MR, Hod EA, Soliman EZ, Gladstone DJ, Healey JS, Sharma M, Chaturvedi S, Janis LS, Krishnaiah B, Nahab F, Kasner SE, Stanton RJ, Kleindorfer DO, Starr M, Winder TR, Clark WM, Miller BR, Elkind MSV; ARCADIA Investigators. Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy: The ARCADIA Randomized Clinical Trial. JAMA. 2024 Feb 20;331(7):573-581. doi: 10.1001/jama.2023.27188.

    PubMed 38324415

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban and Aspirin in people with Stroke, run by Columbia University at 177 sites in 2 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 9 inclusion and 19 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 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Canada. 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 9 Apr 2025). 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 With Recurrent Stroke of Any Type (time frame: Up to 5 years of study participation.). 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 NCT03192215, which also lists 13 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 9 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in