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AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03192215
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : March 19, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Medical University of South Carolina
Bristol-Myers Squibb
Pfizer
Roche Pharma AG
Weill Medical College of Cornell University
University of Washington
Information provided by (Responsible Party):
Mitchell S Elkind, Columbia University

Brief 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.
  • Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

Condition or disease Intervention/treatment Phase
Stroke Drug: Apixaban Drug: Aspirin Phase 3

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 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Eligible patients will be allocated in a 1:1 ratio to apixaban or aspirin using the minimal sufficient balance randomization method to prevent serious treatment imbalances by study site.
Primary Purpose: Prevention
Official Title: AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : January 18, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Active agent: Apixaban
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Drug: Apixaban
5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
Other Name: Eliquis

Active Comparator: Active control: Aspirin
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Drug: Aspirin
Aspirin 81 mg by mouth once daily.
Other Name: Aspirin Tablet




Primary Outcome Measures :
  1. Incidence of recurrent stroke [ Time Frame: 4 years ]
    Recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type)


Secondary Outcome Measures :
  1. Incidence of recurrent ischemic stroke or systemic embolism [ Time Frame: Up to 4 years ]
    Secondary efficacy outcome A

  2. Incidence of recurrent stroke of any type plus death from any cause [ Time Frame: Up to 4 years ]
    Secondary efficacy outcome B

  3. Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke). [ Time Frame: Up to 4 years ]
    Primary safety outcome A

  4. Incidence of major hemorrhage other than intracranial hemorrhage [ Time Frame: Up to 4 years ]
    Primary safety outcome B

  5. Incidence of death from any cause [ Time Frame: Up to 4 years ]
    Secondary safety outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 120 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, 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:

  • History of 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192215


Contacts
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Contact: Mitchell SV Elkind, MD 212 305-1710 mse13@cumc.columbia.edu
Contact: Daniel A Velez, BA 212 305-7755 dav2125@cumc.columbia.edu

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Locations
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United States, Alabama
University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Tammy Davis       trdavis@uabmc.edu   
Principal Investigator: Michael Lyerly, MD         
United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Supreet Kaur, MD       Supreet.Kaur@DignityHealth.org   
Contact: Katy Gilbert       Kathryn.Gilbert@DignityHealth.org   
Principal Investigator: Supreet Kaur, MD         
Banner University Medical Center - Tucson Recruiting
Tucson, Arizona, United States, 85724
Contact: Eddie Soto       esoto@neurology.arizona.edu   
Principal Investigator: Chelsea Kidwell, MD         
United States, California
Eden Medical Center Recruiting
Castro Valley, California, United States, 94546
Contact: Alexandra Ayala    510-727-8267    AyalaA2@sutterhealth.org   
Principal Investigator: Peter R. Adamczyk, MD         
Community Regional Medical Center Recruiting
Fresno, California, United States, 93721
Contact: William Likosky, MD       WLikosky@fresno.ucsf.edu   
Contact: Rebekah Garcia       rgarcia@fresno.ucsf.edu   
Principal Investigator: William Likosky, MD         
Sub-Investigator: Arash Afshinnik, MD         
UCSD Health La Jolla Recruiting
La Jolla, California, United States, 92037
Contact: Theresa McQuaid       tmcquaid@ucsd.edu   
Principal Investigator: Royya Modir, MD         
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Nima Ramezan-Arab, MD       nramezan@gmail.com   
Contact: Françoise Toussaint-Jones       FToussaintJones@memorialcare.org   
Principal Investigator: Nima Ramezan-Arab, MD         
Los Alamitos Medical Center Recruiting
Los Alamitos, California, United States, 90720
Contact: Margaret Villa, RN       Margaret.Villa@tenethealth.com   
Principal Investigator: Nirav Patel, MD         
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Contact: Zahra Ajani, MD       Zahra.A.Ajani@kp.org   
Contact: Catherine L Lui       Catherine.L.Lui@kp.org   
Principal Investigator: Zahra Ajani, MD         
Keck Hospital Of USC Recruiting
Los Angeles, California, United States, 90033
Contact: Nerses Sanossian, MD       Nerses.Sanossian@med.usc.edu   
Contact: Maura Fernandez       Maura.Fernandez@med.usc.edu   
Principal Investigator: Nerses Sanossian, MD         
Los Angeles County- USC Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: Nerses Sanossian, MD       Nerses.Sanossian@med.usc.edu   
Contact: Maura Fernandez       Maura.Fernandez@med.usc.edu   
Principal Investigator: Nerses Sanossian, MD         
VA Greater Los Angeles - West LA VA Medical Center Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Roi A Wallis, MD       RoiAnn.Wallis@med.va.gov   
Contact: Kimberly Panizzon       Kimberly.Panizzon@va.gov   
Principal Investigator: Roi A Wallis, MD         
Scripps Mercy Recruiting
San Diego, California, United States, 91910
Contact: Theresa McQuaid       tmcquaid@ucsd.edu   
Principal Investigator: Royya Modir, MD         
UCSD Medical Center - Hillcrest Hospital Recruiting
San Diego, California, United States, 92103
Contact: Theresa McQuaid       tmcquaid@ucsd.edu   
Principal Investigator: Royya Modir, MD         
Kaiser San Diego Medical Center Recruiting
San Diego, California, United States, 92123
Contact: Sonni Longson       Sonni.x.longson@kp.org   
Principal Investigator: William P. Neil, MD         
Sharp Grossmont Recruiting
San Diego, California, United States, 92123
Contact: Er-Kai Gao, MD       gaoerkai@gmail.com   
Contact: Cary Murphy       Cary.murphy@sharp.com   
Principal Investigator: Er-Kai Gao, MD         
Sharp Memorial Recruiting
San Diego, California, United States, 92123
Contact: Cary Murphy, BSN, CCRC       cary.murphy@sharp.com   
Principal Investigator: Henrik Manassarians, MD         
VA San Diego Healthcare System Not yet recruiting
San Diego, California, United States, 92161
Contact: Karen Rapp       krapp@ucsd.edu   
Principal Investigator: Royya Modir, MD         
Mercy San Juan Medical Center (Dignity Health) Recruiting
San Francisco, California, United States, 94107
Contact: Lucian Maidan Maidan, MD       Lucian.Maidan@DignityHealth.org   
Contact: Danielle Hornbuckle       Danielle.Hornbuckle@DignityHealth.org   
Principal Investigator: Lucian Maidan, MD         
Sub-Investigator: Jason Murray, MD         
San Francisco General Recruiting
San Francisco, California, United States, 94110
Contact: Claude Hemphill, MD       Claude.hemphill@ucsf.edu   
Contact: Jeany Duncan       Jeany.duncan@ucsf.edu   
Principal Investigator: Claude Hemphill, MD         
UCSF Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Karl Meisel, MD       karl.meisel@ucsf.edu   
Contact: Dominica Randazzo       Dominica.Randazzo@ucsf.edu   
Principal Investigator: Karl Meisel, MD         
Regional Medical Center Recruiting
San Jose, California, United States, 95116
Contact: Raul Guisado, MD       guisado.raul@gmail.com   
Contact: Karen De La Cuesta       Karen.DeLaCuesta@hcahealthcare.com   
Principal Investigator: Raul Guisado, MD         
Good Samaritan Recruiting
San Jose, California, United States, 95124
Contact: Harmeet Sachdez, MD       DoctorH@sachdevmd.net   
Contact: Audrey Paulson    408-879-5945    Audrey.Paulson@hcahealthcare.com   
Principal Investigator: Harmeet Sachdez         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Nirali Vora, MD       nirali@stanford.edu   
Contact: Madelleine Garcia       magarcia@stanford.edu   
Principal Investigator: Nirali Vora, MD         
Los Robles Hospital Withdrawn
Thousand Oaks, California, United States, 91360
United States, Colorado
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Alicia Bennett, MD       abennett@carepointhc.com   
Contact: Mark Talley    720-493-3494    Mark.Talley@riaco.com   
Principal Investigator: Alicia Bennett, MD         
St. Mary's Medical Center Recruiting
Grand Junction, Colorado, United States, 81501
Contact: Logan McDaneld, MD       Logan.Mcdaneld@sclhs.net   
Contact: Lisa Bertrand    970-298-7431    Lisa.Bertrand@sclhs.net   
Principal Investigator: Logan McDaneld, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Reshma Narula, MD       reshma.narula@yale.edu   
Contact: Sara Jasak, BSN       sara.jasak@yale.edu   
Principal Investigator: Reshma Narula, MD         
United States, Delaware
Christiana Hospital Recruiting
Newark, Delaware, United States, 19718
Contact: Jonathan Raser-Schramm, MD       jraser-schramm@christianacare.org   
Contact: Amy Cherico    302-733-4189    ACherico@christianacare.org   
Principal Investigator: Jonathan Raser-Schramm, MD         
United States, District of Columbia
Med-star Georgetown Univ. Recruiting
Washington, District of Columbia, United States, 20007
Contact: Andrew Stemer, MD       Andrew.b.stemer@medstar.net   
Contact: Olga Prokunina    202-444-1447    op87@georgetown.edu   
Principal Investigator: Andrew Stemer, MD         
Medstar Washington Recruiting
Washington, District of Columbia, United States, 20010
Contact: Chandni P. Karlaria, MD       Chandni.p.kalaria@medstar.net   
Contact: Preethy K. Feit       Preethy.k.feit@medstar.net   
Principal Investigator: Chandni P. Karlaria, MD         
United States, Florida
UF Health Shands Recruiting
Gainesville, Florida, United States, 32610
Contact: Teddy S. Youn, MD       teddy.youn@neurology.ufl.edu   
Contact: Teresa Lyles       Teresa.Lyles@neurology.ufl.edu   
Principal Investigator: Teddy Youn, MD         
Jackson Memorial Recruiting
Miami, Florida, United States, 33136
Contact: Erika Marulanda-Londono, MD       etm42@med.miami.edu   
Contact: Andrea Escobar, MPH, CCRC       aescobar@med.miami.edu   
Principal Investigator: Erika Marulanda-Londono, MD         
Univ. Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Erika T Marulanda-Londono, MD       etm42@med.miami.edu   
Contact: Andrea Escobar, MPH    (305) 243-8876    aescobar@med.miami.edu   
Principal Investigator: Erika T Marulanda-Londono, MD         
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Contact: Felipe De Los Rios, MD       FelipeDL@baptisthealth.net   
Contact: Josette Elysee       JosetteE@baptisthealth.net   
Principal Investigator: Felipe De Los Rios, MD         
Bruce W. Carter VA Withdrawn
Miami, Florida, United States, 33176
Intercoastal Medical Group - Hyde Park Recruiting
Sarasota, Florida, United States, 34239
Contact: Mauricio Concha, MD       mconcha@intercoastalmedical.com   
Contact: Jeanette Wilson, RN, CCRC       jewilson@intercoastalmedical.com   
Principal Investigator: Mauricio Concha, MD         
Tampa General Recruiting
Tampa, Florida, United States, 33606
Contact: William S. Burgin, MD       wburgin@health.usf.edu   
Contact: Andrea Bozeman       abozeman@helath.usf.edu   
Principal Investigator: William S Burgin, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Fadi Nahab, MD         
Contact: Kiva Schindler       kiva.m.schindler@emory.edu   
Principal Investigator: Fadi Nahab, MD         
Grady Memorial Recruiting
Atlanta, Georgia, United States, 30303
Contact: Mike Frankel, MD       mrfranke@emory.edu   
Contact: Kiva M. Schindler       kiva.m.schindler@emory.edu   
Principal Investigator: Nicolas Bianchi, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Fan Caprio, MD       fan.caprio@nm.org   
Contact: Erin Wymore       erin.wymore@northwestern.edu   
Principal Investigator: Fan Caprio, MD         
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Laurel Cherian, MD       laurel_j_cherian@rush.edu   
Contact: Tiffany Singson    312-563-2208    tiffany_singson@rush.edu   
Principal Investigator: Laurel Cherian, MD         
University of Illinois Recruiting
Chicago, Illinois, United States, 60612
Contact: Fernando Testai, MD       testai@uic.edu   
Contact: Maureen Hillmann       hillmann@uic.edu   
Principal Investigator: Fernando Testai, MD         
Southern Illinois University Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62702
Contact: Fazeel Siddiqui, MD       fsiddiqui@siumed.edu   
Contact: Barbara Lokaitis, MA, CCRP       blokaitis@siumed.edu   
Principal Investigator: Fazeel Siddiqui, MD         
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Contact: Tudor Iacob, MD       mircea.iacob@nm.org   
Contact: Kathleen Hansen       kathy.hansen@nm.org   
Principal Investigator: Tudor Iacob, MD         
United States, Iowa
Mercy Medical Center Not yet recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Michael Jacoby, MD       mjacob@mercydesmoines.org   
Contact: Gena Brown       gbrown@mercydesmoines.org   
Principal Investigator: Michael Jacoby, MD         
Genesis Medical Center Recruiting
Davenport, Iowa, United States, 52804
Contact: Rodney Short, MD       shortr@neurologyqc.com   
Contact: Yvonne Bonick Bonick    563-421-3940    bonicky@genesishealth.com   
Principal Investigator: Rodney Short, MD         
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Enrique Leira, MD       enrique-leira@uiowa.edu   
Contact: Heena M. Olalde, RN    319-356-8326    heena-olalde@uiowa.edu   
Principal Investigator: Enrique Leira, MD         
United States, Kansas
University of Kansas Recruiting
Kansas City, Kansas, United States, 66160
Contact: Aparna Pendurthi., MD       apendurthi2@kumc.edu   
Contact: Alison Boydston       ABOYDSTON@kumc.edu   
Principal Investigator: Michael Rippee, MD         
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: L. Creed Pettigrew, MD, MPH       cpetti@email.uky.edu   
Contact: Patricia Arnold    859-218-5443    pat.arnold@uky.edu   
Principal Investigator: L. Creed Pettigrew, MD, MPH         
University of Louisville Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Tracy Ander, MD       aljerd01@exchange.louisville.edu   
Contact: Pat Wolf       patricia.wolf@louisville.edu   
Principal Investigator: Tracy Ander, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Richard Zweifler, MD       richard.zweifler@ochsner.org   
Contact: Jessica Henry    504-842-8627    jehenry@ochsner.org   
Principal Investigator: Richard Zweifler, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Emiliya Melkumova, MD       EMelkumova@tuftsmedicalcenter.org   
Contact: Sarah Gans       sgans@tuftsmedicalcenter.org   
Principal Investigator: Emiliya Melkumova, MD         
Mass General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Aneesh B. Singhal, MD       asinghal@partners.org   
Contact: Devin Qualls    617-726-4271    DQUALLS@mgh.harvard.edu   
Principal Investigator: Aneesh Singhal, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Julie Shulman, MD       Julie.Shulman@bmc.org   
Contact: Helena Lau       hlau@bu.edu   
Principal Investigator: Julie Shulman, MD         
Beth Israel Deaconess Medical Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sandeep Kumar, MD       skumar@bidmc.harvard.edu   
Contact: Sarah Marchina       smarchin@bidmc.harvard.edu   
Principal Investigator: Sandeep Kumar, MD         
Brigham & Womens Hospital Recruiting
Boston, Massachusetts, United States, 20115
Contact: Steve Feske, MD       sfeske@partners.org   
Contact: Karen Li       kli5@partners.org   
Principal Investigator: Steve Feske, MD         
U Mass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Richard Goddeau, MD       Richard.Goddeau@umassmemorial.org   
Contact: Melissa Adams       Melissa.Adams@umassmed.edu   
Principal Investigator: Richard Goddeau, MD         
Sub-Investigator: Raphael Carandang, MD         
United States, Michigan
Ann Arbor VA Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James Burke, MD    734-764-5871    jamesbur@med.umich.edu   
Contact: Nicholas Buhay       buhaynic@med.umich.edu   
Principal Investigator: James Burke, MD         
University of Michigan University Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: James Burke, MD       jamesbur@med.umich.edu   
Contact: Patty Johnson       johnspat@med.umich.edu   
Principal Investigator: James Burke, MD         
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Kumar Rajamani, MD, DM       krajaman@med.wayne.edu   
Contact: Amy Spencer    313-745-7836    aspencer@med.wayne.edu   
Principal Investigator: Kumar Rajamani, MD, DM         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Angelos Katramados, MD       akatram1@hfhs.org   
Contact: Janet Kandrevas       jkandre1@hfhs.org   
Principal Investigator: Angelos Katramados, MD         
McLaren Flint Recruiting
Flint, Michigan, United States, 48532
Contact: Aniel Majjhoo, MD       aniel.majjhoo@mclaren.org   
Contact: Jill George       jill.george@mclaren.org   
Principal Investigator: Aniel Majjhoo, MD         
Mercy Health St. Mary's Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Christopher Goshgarian, MD       farooqmu@mercyhealth.com   
Contact: Julie Bishop       Julie.A.Bishop@mercyhealth.com   
Principal Investigator: Christopher Goshgarian, MD         
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Muhib Khan, MD       Muhib.Khan@spectrumhealth.org   
Contact: Christa Rood       Christa.Rood@spectrumhealth.org   
Principal Investigator: Muhib Khan, MD         
United States, Minnesota
Abbot Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Mark Young, MD       myoung@noranclinic.com   
Contact: Kayla Sternagle       kayla.stiernagle@allina.com   
Principal Investigator: Mark Young, MD         
Hennepin County Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Ivan R Matos Diaz, MD       ivan.matosd@gmail.com   
Contact: Chloe Lawyer       lawye010@umn.edu   
Principal Investigator: Ivan R Matos Diaz, MD         
Univ. of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ben Miller, MD       brmille@umn.edu   
Contact: Amanda Weller       andv0003@umn.edu   
Principal Investigator: Ben Miller, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Alejandro Rabinstein, MD       rabinstein.alejandro@mayo.edu   
Contact: Amy Headlee       Headlee.Amy@mayo.edu   
Principal Investigator: Alejandro Rabinstein, MD         
Regions Hospital, St. Paul Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Haitham Hussein, MD       Haitham.M.Hussein@HealthPartners.com   
Contact: Maria Pyle       Maria.X.Pyle@HealthPartners.Com   
Principal Investigator: Haitham Hussein, MD         
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Ganesh Asaithambi, MD       Ganesh.asaithambi@allina.com   
Contact: Bridget Ho, CCRC       bridget.ho@allina.com   
Principal Investigator: Ganesh Asaithambi, MD         
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jin-Moo Lee, MD       leejm@wustl.edu   
Contact: Jennifer Babka       babkaj@wustl.edu   
Principal Investigator: Jin-Moo Lee, MD         
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68198
Contact: Pierre Fayad, MD       pfayad@unmc.edu   
Contact: Gretchen Naumann         
Principal Investigator: Pierre Fayad, MD         
United States, New Jersey
Robert Wood Johnson Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Deviyani Mehta, MD       dm1125@rwjms.rutgers.edu   
Contact: Michelle Moccio       mocciomi@rwjms.rutgers.edu   
Principal Investigator: Deviyani Mehta, MD         
St. Josephs Regional Withdrawn
Paterson, New Jersey, United States, 07503-2621
United States, New Mexico
Univ. New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Atif Zafar, MD       azafr@salud.unm.edu   
Contact: Amal Alchbli       aalchbli@salud.unm.edu   
Principal Investigator: Atif Zafar, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Kathryn Kirchoff-Torres, MD       kkirchof@montefiore.org   
Contact: Khadean Moncrieffe       kmoncrie@montefiore.org   
Principal Investigator: Kathryn Kirchoff-Torres, MD         
Kings County Hospital Recruiting
Brooklyn, New York, United States, 11203
Contact: Susan W. Law, DO       susan.law@nychhc.org   
Contact: Yelena Ilyasova, NP    718-245-1311    Yelene.Ilyasova@nychhc.org   
Principal Investigator: Susan W. Law, DO         
New York Presbyterian - Brooklyn Methodist Hospital Not yet recruiting
Brooklyn, New York, United States, 11215-3609
Contact: Jeffrey Benjamin, MD       jlb9013@nyp.org   
Contact: Jonathan Muller, MBA    718.780.3777    jsm9013@nyp.org   
Principal Investigator: Jeffrey Benjamin, MD         
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Steven Rudolph, MD       SRudolph@maimonidesmed.org   
Contact: Holly Morhaim       hmorhaim@maimonidesmed.org   
Principal Investigator: Steven Rudolph, MD         
Buffalo General Medical Center Recruiting
Buffalo, New York, United States, 14203
Contact: Robert N Sawyer, MD       Robertsa@buffalo.edu   
Contact: Annemarie Crumlish    716-829-5046    ac35@buffalo.edu   
Principal Investigator: Robert N Sawyer, MD         
NYU Langone Recruiting
New York, New York, United States, 10003
Contact: Jose Torres, MD       jose.torres2@nyumc.org   
Contact: Thomas Callahan       Thomas.Calahan@nyumc.org   
Principal Investigator: Jose Torres, MD         
Mount Sinai West Recruiting
New York, New York, United States, 10019
Contact: Carolyn Brockington, MD       cbrockin@chpnet.org   
Contact: Ricardo Renvill       ricardo.renvill@mssm.edu   
Principal Investigator: Carolyn Brockington, MD         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Michell SV Elkind, MD    212-305-1710    mse13@cumc.columbia.edu   
Contact: Daniel Velez    212.305.7755    dav2125@cumc.columbia.edu   
Principal Investigator: Eliza Miller, MD         
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Hooman Kamel, MD       hok9010@med.cornell.edu   
Contact: Carla Pisarro Sherman    212.746.6757    cas9149@med.cornell.edu   
Principal Investigator: Hooman Kamel, MD         
United States, North Dakota
Sanford Medical Center Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Michael Manchak, MD       michael.manchak@sanfordhealth.org   
Contact: Destini Spaeth       destini.spaeth@sanfordhealth.org   
Principal Investigator: Michael Manchak, MD         
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Dawn Kleindorfer, MD       Dawn.kelindorfer@uc.edu   
Contact: Emily Goodall       goodaleb@ucmail.uc.edu   
Principal Investigator: Dawn Kleindorfer, MD         
Louis Stokes VA Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Svetlana Pundik, MD    877-838-8262    sxp19@case.edu   
Contact: Lisa Tucker, RN    216-791-3800    Lisa.Tucker@va.gov   
Principal Investigator: Svetlana Pundik, MD         
UH Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sophia Sundararajan, MD       Sophia.Sundararajan@UHhospitals.org   
Contact: David Korosec, RN       David.Korosec@UHhospitals.org   
Principal Investigator: Sophia Sundararajan, MD         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Joseph Hanna, MD       jhanna@metrohealth.org   
Contact: Dana Cook       dcook@metrohealth.org   
Principal Investigator: Joseph Hanna, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Dolora Wisco, MD       WISCOD@ccf.org   
Contact: Erin Bynum       bynume@ccf.org   
Principal Investigator: Dolora Wisco, MD         
OSU Wexner Recruiting
Columbus, Ohio, United States, 43210
Contact: Shraddha Mainali, MD       Shraddha.Mainali@osumc.edu   
Contact: Arielle Smith       arielle.smith@osumc.edu   
Principal Investigator: Shradda Mainali, MD         
Ohio Health Riverside - Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Nora Vora, MD       NVora@riversiderad.com   
Contact: Katy Groezinger, BSN       Katy.Groezinger@ohiohealth.com   
Principal Investigator: Nora Vora, MD         
Mercy Health St Vincent Recruiting
Toledo, Ohio, United States, 43608
Contact: Osama Zaidat, MD       OZaidat@mercy.com   
Contact: Melissa Thomas, RN       MThomas@mercy.com   
Principal Investigator: Osama Zaidat, MD         
United States, Oklahoma
OU Medical Center Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Evgeny Sidorov, MD       evgeny-sidorov@ouhsc.edu   
Contact: Blair Apple    405-271-4658    Blair-Apple@ouhsc.edu   
Principal Investigator: Evgeny Sidorov, MD         
St. John Medical Center Suspended
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Legacy Emanuel Suspended
Portland, Oregon, United States, 97227
Oregon Health and Sciences Recruiting
Portland, Oregon, United States, 97239
Contact: Hormozd Bozorgchami, MD       bozorgch@ohsu.edu   
Contact: Kathy Lee    503-494-7191    leekathy@ohsu.edu   
Principal Investigator: Hormozd Bozorgchami, md         
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Hussam A Yacoub, MD       Hussam_A.Yacoub@lvhn.org   
Contact: Andrew Orzel       Andrew.Orzel@lvhn.org   
Principal Investigator: Hussam A Yacoub, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Scott Kasner, MD       kasner@mail.med.upenn.edu   
Contact: Devin Keating       devin.keating@uphs.upenn.edu   
Principal Investigator: Scott Kasner, MD         
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Paul Katz, MD       Paul.Katz@tuhs.temple.edu   
Contact: Hannah Reimer       Hannah.Reimer@tuhs.temple.edu   
Principal Investigator: Paul Katz, MD         
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Matthew Starr, MD       starrmt2@upmc.edu   
Contact: Cathy Van Every       vaneverycc@ph.upmc.edu   
Principal Investigator: Matthew Starr, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Chirantan Banerjee, MD       banerjeec@musc.edu   
Contact: Cheryl Grant       grantche@musc.edu   
Principal Investigator: Chirantan Banerjee, MD         
Palmetto Health Recruiting
Columbia, South Carolina, United States, 29203
Contact: Sen Souvik, MD       Souvik.Sen@uscmed.sc.edu   
Contact: Brittiny McMillian       Brittiny.McMillian@uscmed.sc.edu   
Principal Investigator: Sen Souvik, MD         
Sub-Investigator: Tushar Trivedi, MD         
Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Fanny Guillerminet       FGuillerminet@ghs.org   
Principal Investigator: Paulo Zortea, MD         
United States, Tennessee
Fort Sanders Regional Medical Center Withdrawn
Knoxville, Tennessee, United States, 37916
Vanderbilt Recruiting
Nashville, Tennessee, United States, 37212
Contact: Michael Froehler, MD       m.froehler@vanderbilt.edu   
Contact: Drew Anderson       drew.anderson@vumc.org   
Principal Investigator: Michael Froehler, MD         
United States, Texas
UT Southwestern Medical Center Suspended
Dallas, Texas, United States, 75390
Valley Bapist Recruiting
Harlingen, Texas, United States, 78550
Contact: Ameer Hassan, MD       ameerehassan@gmail.com   
Contact: Olive Sanchez    956.491.9622    olive.sanchez@valleybaptist.net   
Principal Investigator: Ameer Hassan, MD         
Baylor College College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Rahul Damani, MD       Rahul.Damani@bcm.edu   
Contact: Emily Jobe       Emilia.Jobe@bcm.edu   
Principal Investigator: Rahul Damani, MD         
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Vivek Misra, MD       vmisra@houstonmethodist.org   
Contact: Jason Lee, RN         
Principal Investigator: Vivek Misra, MD         
Memorial Herman Recruiting
Houston, Texas, United States, 77030
Contact: Anjail Z. Sharrief, MD       Anjail.Z.Sharrief@uth.tmc.edu   
Contact: Gabretta Cooksey    713-500-7153    Gabretta.Cooksey@uth.tmc.edu   
Principal Investigator: Anajail Sharrief, MD         
UT Health Sciences San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Reza Behrouz, MD       Behrouz@uthscsa.edu   
Contact: Jody Richardson       richardsonj1@uthscsa.edu   
Principal Investigator: Reza Behrouz, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84107
Contact: Megan Donohue, MD       Megan.Donohue@imail.org   
Contact: Jacki Anderson    801.507.6453    Jacki.Anderson@imail.org   
Principal Investigator: Megan Donohue, MD         
Utah Valley Regional Medical Center Recruiting
Provo, Utah, United States, 84604
Contact: Kevin Call, MD       Kevin.Call@imail.org   
Contact: Shane Jones       Shane.Jones@imail.org   
Principal Investigator: Kevin Call, MD         
Univ of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Peter M. Hannon, MD       Peter.Hannon@hsc.utah.edu   
Contact: Kinga Aitken    801-581-5523    kinga.aitken@hsc.utah.edu   
Principal Investigator: Peter Hannon, MD         
George E Whalen VA Not yet recruiting
Salt Lake City, Utah, United States, 84148
Contact: Jana Wold, MD       Jana.Wold@hsc.utah.edu   
Contact: Kinga Aitken       kinga.aitken@hsc.utah.edu   
Principal Investigator: Jana Wold, MD         
Sub-Investigator: Lee Chung, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Brad Worrall, MD       BBW9R@hscmail.mcc.virgina.edu   
Contact: Heather Haughey       HMH8F@hscmail.mcc.virginia.edu   
Principal Investigator: Brad Worrall, MD         
United States, Washington
Providence St. Peter Hospital Recruiting
Olympia, Washington, United States, 98506
Contact: Corey White, MD       Corey.White@providence.org   
Contact: David Howell       David.howell@providence.org   
Principal Investigator: Corey White, MD         
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: David Tirschwell, MD       tirsch@uw.edu   
Contact: Allison Kunze       kunzea@uw.edu   
Principal Investigator: David Tirschwell, MD         
Puget Sound VA Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Andrew Huffer Huffer, MD       Andrew.Huffer@va.gov   
Contact: Sharon McRae       Sharon.McRae@va.gov   
Principal Investigator: Andrew Huffer, MD         
Swedish Medical Center - Cherry Hill Campus Recruiting
Seattle, Washington, United States, 98122
Contact: Sheila Smith Smith, MD       Sheila.Smith@swedish.org   
Contact: Cheryl Kelly, RN    206-320-3695    cheryl.kelly@swedish.org   
Principal Investigator: Sheila Smith, MD         
Principal Investigator: Nirav Shah, MD         
United States, West Virginia
WVU Healthcare Ruby Memorial Recruiting
Morgantown, West Virginia, United States, 26506-9180
Contact: Alvi Muhammad, MD       muhammad.alvi@hsc.wvu.edu   
Contact: Jay Sherman    304-293-3527    shermanj@wvumedicine.org   
Principal Investigator: Avi Muhammad, MD         
United States, Wisconsin
Univer of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Edward Luke Bradbury, MD       bradbury@neurology.wisc.edu   
Contact: Stephanie Armstrong       armstrong@neurosurgery.wisc.edu   
Principal Investigator: Edward L. Bradbury, MD         
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Rehan Sejjad, MD       rehan.sejjad@aurora.org   
Contact: Kate McPolin    414.385.7125    Kate.McPolin@aurora.org   
Principal Investigator: Rehan Sejjad, MD         
Sponsors and Collaborators
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
University of Cincinnati
Medical University of South Carolina
Bristol-Myers Squibb
Pfizer
Roche Pharma AG
Weill Medical College of Cornell University
University of Washington
Investigators
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Principal Investigator: Mitchell SV Elkind, MD Columbia University

Additional Information:
Publications:
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Responsible Party: Mitchell S Elkind, Professor of Neurology and Epidemiology in the Gertrude H. Serg, Department of Neurology Stroke, Columbia University
ClinicalTrials.gov Identifier: NCT03192215     History of Changes
Other Study ID Numbers: AAAR4607
1U01NS095869-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mitchell S Elkind, Columbia University:
Atrial Cardiopathy
Cryptogenic stroke
Ischemic stroke
Apixaban
Aspirin
Additional relevant MeSH terms:
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Stroke
Heart Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Apixaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants