AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
NCT ID: NCT03192215
Last Updated: 2025-04-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1015 participants
INTERVENTIONAL
2018-01-19
2023-04-17
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
PREVENTION
QUADRUPLE
Study Groups
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Active agent: Apixaban
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Apixaban
5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
Active control: Aspirin
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Aspirin
Aspirin 81 mg by mouth once daily.
Interventions
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Apixaban
5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
Aspirin
Aspirin 81 mg by mouth once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
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)
45 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Cincinnati
OTHER
Medical University of South Carolina
OTHER
Bristol-Myers Squibb
INDUSTRY
Pfizer
INDUSTRY
Roche Pharma AG
INDUSTRY
Weill Medical College of Cornell University
OTHER
University of Washington
OTHER
Columbia University
OTHER
Responsible Party
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Randolph S. Marshall, MD
Elisabeth K Harris Professor of Neurology Chief, Stroke Division
Principal Investigators
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Randolph S Marshall, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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University of Alabama
Birmingham, Alabama, United States
University of South Alabama University Hospital
Mobile, Alabama, United States
Chandler Regional Medical Center Chandler, AZ
Chandler, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Mercy San Juan Medical Center (Dignity Health)
Carmichael, California, United States
Eden Medical Center
Castro Valley, California, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, United States
Community Regional Medical Center
Fresno, California, United States
UCSD Health La Jolla
La Jolla, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Los Alamitos Medical Center
Los Alamitos, California, United States
Kaiser Permanente
Los Angeles, California, United States
Keck Hospital Of USC
Los Angeles, California, United States
Los Angeles County- USC Medical Center
Los Angeles, California, United States
VA Greater Los Angeles - West LA VA Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Sutter Medical Center
Sacramento, California, United States
Salinas Valley Memorial Hospital
Salinas, California, United States
Scripps Mercy
San Diego, California, United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States
Kaiser Permanent San Diego Medical Center
San Diego, California, United States
Sharp Memorial Hospital
San Diego, California, United States
San Francisco General
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Good Samaritan
San Jose, California, United States
Stanford University Medical Center
Stanford, California, United States
Swedish Medical Center
Englewood, Colorado, United States
St. Mary's Medical Center
Grand Junction, Colorado, United States
St. Vincent's Medical Center
Bridgeport, Connecticut, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Med-star Georgetown Univ.
Washington D.C., District of Columbia, United States
Medstar Washington
Washington D.C., District of Columbia, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
UF Health Shands
Gainesville, Florida, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Jackson Memorial
Miami, Florida, United States
Univ. Miami Hospital
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Intercoastal Medical Group - Hyde Park
Sarasota, Florida, United States
Tampa General
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Grady Memorial
Atlanta, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
OSF St. Francis Medical Center
Peoria, Illinois, United States
Southern Illinois University Memorial Medical Center
Springfield, Illinois, United States
St. John's Hospital (Prairie Research)
Springfield, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
Multi-Specialty - Methodist Plaza/Unity Point
Des Moines, Iowa, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical
Boston, Massachusetts, United States
Brigham & Womens Hospital
Boston, Massachusetts, United States
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States
U Mass Memorial Medical Center
Worcester, Massachusetts, United States
University of Michigan University Hospital
Ann Arbor, Michigan, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
McLaren Flint
Flint, Michigan, United States
Mercy Health St. Mary's
Grand Rapids, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
McLaren Macomb, Mount Clemens, MI
Mount Clemens, Michigan, United States
McLaren Northern Michigan
Petoskey, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County
Minneapolis, Minnesota, United States
Univ. of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Regions Hospital, St. Paul
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Cox Medical Center South
Springfield, Missouri, United States
St. Louis University Hospital
St Louis, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
CHI Health Immanuel
Omaha, Nebraska, United States
University of Nebraska
Omaha, Nebraska, United States
Cooper University Hospital,
Camden, New Jersey, United States
Robert Wood Johnson
New Brunswick, New Jersey, United States
Capital Health Medical Center Hopewell
Pennington, New Jersey, United States
Univ. New Mexico
Albuquerque, New Mexico, United States
Kings County Hospital
Brooklyn, New York, United States
New York Presbyterian - Brooklyn Methodist Hospital
Brooklyn, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York, United States
Mount Sinai Beth Israel Brooklyn
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Langone
New York, New York, United States
Mount Sinai West
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Strong Memorial Hospital
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Sanford Medical Center Fargo
Fargo, North Dakota, United States
Akron General Medical Center
Akron, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Louis Stokes VA Medical Center
Cleveland, Ohio, United States
UH Cleveland Medical Center
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
OSU Wexner
Columbus, Ohio, United States
Ohio Health Riverside - Riverside Methodist Hospital
Columbus, Ohio, United States
Miami Valley Hospita
Dayton, Ohio, United States
Mercy St Vincent Medical Center
Toledo, Ohio, United States
OU Medical Center Oklahoma
Oklahoma City, Oklahoma, United States
Legacy Emanuel
Portland, Oregon, United States
Oregon Health and Sciences
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
UPMC Altoona
Altoona, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health Richland Hospital (formerly Palmetto Health)
Columbia, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Methodist University Hospital
Memphis, Tennessee, United States
Vanderbilt
Nashville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Valley Bapist
Harlingen, Texas, United States
Baylor College College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Univ of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Scott & White Memorial Hospital - Temple
Temple, Texas, United States
Memorial Hermann The Woodlands Hospital
The Woodlands, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
Univ of Utah
Salt Lake City, Utah, United States
George E Whalen VA
Salt Lake City, Utah, United States
UVA Medical Center
Charlottesville, Virginia, United States
Bon Secours St. Mary's Hospital
Richmond, Virginia, United States
Providence St. Peter Hospital
Olympia, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Puget Sound VA
Seattle, Washington, United States
Swedish Medical Center - Cherry Hill Campus
Seattle, Washington, United States
WVU Healthcare Ruby Memorial
Morgantown, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Froedtert Hospital
Milwaukee, Wisconsin, United States
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Neurologic Research Center
Lethbridge, Alberta, Canada
Kelowna General Hospital
Kelowna, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Brandon Regional Health Center
Brandon, Manitoba, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Enfant-Jesus Hospital
Québec, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
NIH/NINDS StrokeNet Prevention trials website
ARCADIA Trial Video
Other Identifiers
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AAAR4607
Identifier Type: -
Identifier Source: org_study_id
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