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Trial record 1 of 493 for:    Recruiting Studies | atrial cardiopathy
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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 : May 22, 2020
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 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.

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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: 7 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 7 years ]
    Secondary efficacy outcome A

  2. Incidence of recurrent stroke of any type plus death from any cause [ Time Frame: Up to 7 years ]
    Secondary efficacy outcome B

  3. Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke). [ Time Frame: Up to 7 years ]
    Primary safety outcome A

  4. Incidence of major hemorrhage other than intracranial hemorrhage [ Time Frame: Up to 7 years ]
    Primary safety outcome B

  5. Incidence of death from any cause [ Time Frame: Up to 7 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 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, 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.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.

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: Rebeca Aragon Garcia, BS 212 342-0102 ra2356@cumc.columbia.edu

Locations
Hide Hide 159 study locations
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United States, Alabama
University of Alabama Suspended
Birmingham, Alabama, United States, 35233
University of South Alabama University Hospital Suspended
Mobile, Alabama, United States, 36604
United States, Arizona
Chandler Regional Medical Center Chandler, AZ Suspended
Chandler, Arizona, United States, 85224
St. Joseph's Hospital and Medical Center Suspended
Phoenix, Arizona, United States, 85013
Banner University Medical Center - Tucson Suspended
Tucson, Arizona, United States, 85724
United States, Arkansas
UAMS Medical Center Suspended
Little Rock, Arkansas, United States, 72205
United States, California
Mercy San Juan Medical Center (Dignity Health) Suspended
Carmichael, California, United States, 95608
Eden Medical Center Suspended
Castro Valley, California, United States, 94546
Rancho Los Amigos National Rehabilitation Center Suspended
Downey, California, United States, 90242
Community Regional Medical Center Suspended
Fresno, California, United States, 93721
UCSD Health La Jolla Suspended
La Jolla, California, United States, 92037
Sharp Grossmont Hospital Recruiting
La Mesa, California, United States, 92123
Contact: Cary Murphy       Cary.murphy@sharp.com   
Contact: Yu Cheng, MD       yu.cheng@sharp.com   
Principal Investigator: Yu Cheng, MD         
Long Beach Memorial Medical Center Suspended
Long Beach, California, United States, 90806
Los Alamitos Medical Center Suspended
Los Alamitos, California, United States, 90720
Kaiser Permanente Suspended
Los Angeles, California, United States, 90027
Keck Hospital Of USC Suspended
Los Angeles, California, United States, 90033
Los Angeles County- USC Medical Center Suspended
Los Angeles, California, United States, 90033
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         
Ronald Reagan UCLA Medical Center Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Jeffrey Saver, MD       JSaver@mednet.ucla.edu   
Contact: Gilda Avila       gavila@mednet.ucla.edu   
Principal Investigator: Jeffrey Saver, MD         
Sutter Medical Center Not yet recruiting
Sacramento, California, United States, 95816
Contact: Manoj Mittal, MD       mittalmk@sutterhealth.org   
Contact: Tammy Donnel       donnelt@sutterhealth.org   
Principal Investigator: Manoj Mittal, MD         
Salinas Valley Memorial Hospital Suspended
Salinas, California, United States, 93901
Scripps Mercy Suspended
San Diego, California, United States, 91910
UCSD Medical Center - Hillcrest Hospital Suspended
San Diego, California, United States, 92103
Kaiser Permanent San Diego Medical Center Suspended
San Diego, California, United States, 92123
Sharp Memorial Hospital Suspended
San Diego, California, United States, 92123
San Francisco General Suspended
San Francisco, California, United States, 94110
UCSF Medical Center Suspended
San Francisco, California, United States, 94143
Regional Medical Center Withdrawn
San Jose, California, United States, 95116
Good Samaritan Terminated
San Jose, California, United States, 95124
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 Suspended
Englewood, Colorado, United States, 80113
St. Mary's Medical Center Suspended
Grand Junction, Colorado, United States, 81501
United States, Connecticut
Hartford Hospital Suspended
Hartford, Connecticut, United States, 06102-5037
Yale New Haven Hospital Suspended
New Haven, Connecticut, United States, 06520
United States, Delaware
Christiana Hospital Suspended
Newark, Delaware, United States, 19718
United States, District of Columbia
Med-star Georgetown Univ. Suspended
Washington, District of Columbia, United States, 20007
Medstar Washington Suspended
Washington, District of Columbia, United States, 20010
United States, Florida
UF Health Shands Suspended
Gainesville, Florida, United States, 32610
Mayo Clinic Suspended
Jacksonville, Florida, United States, 32224
Jackson Memorial Suspended
Miami, Florida, United States, 33136
Univ. Miami Hospital Suspended
Miami, Florida, United States, 33136
Baptist Hospital of Miami Suspended
Miami, Florida, United States, 33176
Bruce W. Carter VA Withdrawn
Miami, Florida, United States, 33176
Intercoastal Medical Group - Hyde Park Suspended
Sarasota, Florida, United States, 34239
Tampa General Suspended
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Suspended
Atlanta, Georgia, United States, 30303
Grady Memorial Suspended
Atlanta, Georgia, United States, 30303
United States, Hawaii
The Queen's Medical Center Not yet recruiting
Honolulu, Hawaii, United States, 96813
Contact: Rony Salem, MD       rsalem@queens.org   
Contact: Tracy Stern       tstern@queens.org   
Principal Investigator: Rony Salem, MD         
United States, Illinois
Northwestern Memorial Hospital Suspended
Chicago, Illinois, United States, 60611
Rush University Suspended
Chicago, Illinois, United States, 60612
University of Illinois Suspended
Chicago, Illinois, United States, 60612
University of Chicago Medical Center Suspended
Chicago, Illinois, United States, 60637
OSF St. Francis Medical Center Suspended
Peoria, Illinois, United States, 61637
Southern Illinois University Memorial Medical Center Terminated
Springfield, Illinois, United States, 62702
Central DuPage Hospital Suspended
Winfield, Illinois, United States, 60190
United States, Iowa
Mercy Medical Center Withdrawn
Cedar Rapids, Iowa, United States, 52403
Genesis Medical Center West Withdrawn
Davenport, Iowa, United States, 52803
Genesis Medical Center Withdrawn
Davenport, Iowa, United States, 52804
University of Iowa Suspended
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Suspended
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Kentucky Suspended
Lexington, Kentucky, United States, 40536
University of Louisville Hospital Suspended
Louisville, Kentucky, United States, 40202
United States, Louisiana
Ochsner Medical Center Suspended
New Orleans, Louisiana, United States, 70121
United States, Maine
Eastern Maine Medical Center Suspended
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland Medical Center Suspended
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts Medical Center Suspended
Boston, Massachusetts, United States, 02111
Mass General Hospital Suspended
Boston, Massachusetts, United States, 02114
Boston Medical Center Suspended
Boston, Massachusetts, United States, 02118
Beth Israel Deaconess Medical Suspended
Boston, Massachusetts, United States, 02215
Brigham & Womens Hospital Suspended
Boston, Massachusetts, United States, 20115
Lahey Hospital & Medical Center Not yet recruiting
Burlington, Massachusetts, United States, 01805
Contact: Catia Melo       Catia.S.Melo@lahey.org   
Contact: Siddharth Sehgal, MD       siddharth.sehgal@lahey.org   
Principal Investigator: Siddharth Siddharth Sehgal, MD         
U Mass Memorial Medical Center Suspended
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan University Hospital Suspended
Ann Arbor, Michigan, United States, 48109
VA Ann Arbor Healthcare System Suspended
Ann Arbor, Michigan, United States, 48109
Detroit Receiving Hospital Suspended
Detroit, Michigan, United States, 48201
Henry Ford Hospital Suspended
Detroit, Michigan, United States, 48202
McLaren Flint Suspended
Flint, Michigan, United States, 48532
Mercy Health St. Mary's Suspended
Grand Rapids, Michigan, United States, 49503
Spectrum Health Suspended
Grand Rapids, Michigan, United States, 49503
McLaren Macomb, Mount Clemens, MI Suspended
Mount Clemens, Michigan, United States, 48043
United States, Minnesota
Abbot Northwestern Hospital Suspended
Minneapolis, Minnesota, United States, 55407
Hennepin County Suspended
Minneapolis, Minnesota, United States, 55415
Univ. of Minnesota Suspended
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Suspended
Rochester, Minnesota, United States, 55905
Regions Hospital, St. Paul Terminated
Saint Paul, Minnesota, United States, 55101
United Hospital Suspended
Saint Paul, Minnesota, United States, 55102
United States, Mississippi
University of Mississippi Medical Center Suspended
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Louis University Hospital Not yet recruiting
Saint Louis, Missouri, United States, 63104
Contact: Andre Guthrie       andre.guthrie@health.slu.edu   
Contact: Randall Edgell, MD       redgell@slu.edu   
Principal Investigator: Randall Edgell, MD         
Barnes Jewish Hospital Suspended
Saint Louis, Missouri, United States, 63110
Cox Medical Center South Suspended
Springfield, Missouri, United States, 65807
United States, Nebraska
University of Nebraska Suspended
Omaha, Nebraska, United States, 68198
United States, New Jersey
Robert Wood Johnson Suspended
New Brunswick, New Jersey, United States, 08901
St. Josephs Regional Withdrawn
Paterson, New Jersey, United States, 07503-2621
Capital Health Medical Center Hopewell Suspended
Pennington, New Jersey, United States, 08534
United States, New Mexico
Univ. New Mexico Suspended
Albuquerque, New Mexico, United States, 87131
United States, New York
Montefiore Medical Center Suspended
Bronx, New York, United States, 10467
Kings County Hospital Suspended
Brooklyn, New York, United States, 11203
New York Presbyterian - Brooklyn Methodist Hospital Suspended
Brooklyn, New York, United States, 11215-3609
Maimonides Medical Center Suspended
Brooklyn, New York, United States, 11219
NYU Langone Hospital - Brooklyn Suspended
Brooklyn, New York, United States, 11220
Mount Sinai Beth Israel Brooklyn Suspended
Brooklyn, New York, United States, 11234
Buffalo General Medical Center Suspended
Buffalo, New York, United States, 14203
North Shore University Hospital Suspended
Manhasset, New York, United States, 11042
NYU Langone Suspended
New York, New York, United States, 10003
Mount Sinai West Suspended
New York, New York, United States, 10019
Columbia University Medical Center Suspended
New York, New York, United States, 10032
Weill Cornell Medicine Suspended
New York, New York, United States, 10065
Lenox Hill Hospital Suspended
New York, New York, United States, 10075
Strong Memorial Hospital Suspended
Rochester, New York, United States, 14642
United States, North Carolina
Mission Hospital Memorial Campus Not yet recruiting
Asheville, North Carolina, United States, 28801
Contact: Tracy Nanney       Tracy.Nanney@HCAHealthcare.com   
Contact: Alexander Schneider, MD       Alexander.Schneider@HCAHealthcare.com   
Principal Investigator: Alexander Schneider, MD         
Moses H. Cone Memorial Hospital Suspended
Greensboro, North Carolina, United States, 27405
Wake Forest Baptist Medical Center Suspended
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Sanford Medical Center Fargo Suspended
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron General Medical Center Not yet recruiting
Akron, Ohio, United States, 44307
Contact: James Gebel, MD       GebelJ2@ccf.org   
Contact: Debra Hudock       HudockD@ccf.org   
Principal Investigator: James Gebel, MD         
University of Cincinnati Suspended
Cincinnati, Ohio, United States, 45219
Louis Stokes VA Medical Center Suspended
Cleveland, Ohio, United States, 44106
UH Cleveland Medical Center Suspended
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center Suspended
Cleveland, Ohio, United States, 44109
Cleveland Clinic Suspended
Cleveland, Ohio, United States, 44195
OSU Wexner Suspended
Columbus, Ohio, United States, 43210
Ohio Health Riverside - Riverside Methodist Hospital Suspended
Columbus, Ohio, United States, 43214
Miami Valley Hospita Suspended
Dayton, Ohio, United States, 45409
Mercy Health St Vincent Suspended
Toledo, Ohio, United States, 43608
United States, Oklahoma
OU Medical Center Oklahoma Suspended
Oklahoma City, Oklahoma, United States, 73104
St. John Medical Center Withdrawn
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Legacy Emanuel Terminated
Portland, Oregon, United States, 97227
Oregon Health and Sciences Suspended
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lehigh Valley Hospital Suspended
Allentown, Pennsylvania, United States, 18103
Hospital of the University of Pennsylvania Suspended
Philadelphia, Pennsylvania, United States, 19104
Temple University Suspended
Philadelphia, Pennsylvania, United States, 19140
UPMC Presbyterian Suspended
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital Suspended
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina Suspended
Charleston, South Carolina, United States, 29425
Prisma Health Richland Hospital (formerly Palmetto Health) Suspended
Columbia, South Carolina, United States, 29203
Greenville Hospital System Suspended
Greenville, South Carolina, United States, 29605
United States, Tennessee
Fort Sanders Regional Medical Center Withdrawn
Knoxville, Tennessee, United States, 37916
Methodist University Hospital Not yet recruiting
Memphis, Tennessee, United States, 38104
Contact: Balaji KRISHNAIAH, MD       bkrishn4@uthsc.edu   
Contact: Quentin Thacker       qthacker@uthsc.edu   
Principal Investigator: Balaji KRISHNAIAH, MD         
Vanderbilt Suspended
Nashville, Tennessee, United States, 37212
United States, Texas
UT Southwestern Medical Center Suspended
Dallas, Texas, United States, 75390
DHR Health Not yet recruiting
Edinburg, Texas, United States, 78539
Contact: Wady Aude, MD       wady.aude@UTRGV.edu   
Contact: Annelise Hernandez       Annel.hernandez@dhr-rgv.com   
Principal Investigator: Wady Aude, MD         
Valley Bapist Recruiting
Harlingen, Texas, United States, 78550
Contact: Ameer Hassan, MD       Ameer.hassan@valleybaptist.net   
Contact: Olive Sanchez    956.491.9622    olive.sanchez@valleybaptist.net   
Principal Investigator: Ameer Hassan, MD         
Baylor College College of Medicine Suspended
Houston, Texas, United States, 77030
Houston Methodist Hospital Suspended
Houston, Texas, United States, 77030
Memorial Hermann Texas Medical Center Suspended
Houston, Texas, United States, 77030
Univ of Texas Health Science Center San Antonio Suspended
San Antonio, Texas, United States, 78229
United States, Utah
Intermountain Medical Center Suspended
Murray, Utah, United States, 84107
Utah Valley Regional Medical Center Suspended
Provo, Utah, United States, 84604
Univ of Utah Suspended
Salt Lake City, Utah, United States, 84132
George E Whalen VA Suspended
Salt Lake City, Utah, United States, 84148
United States, Virginia
UVA Medical Center Suspended
Charlottesville, Virginia, United States, 22908
United States, Washington
Providence St. Peter Hospital Suspended
Olympia, Washington, United States, 98506
Harborview Medical Center Suspended
Seattle, Washington, United States, 98104
Puget Sound VA Suspended
Seattle, Washington, United States, 98108
Swedish Medical Center - Cherry Hill Campus Suspended
Seattle, Washington, United States, 98122
United States, West Virginia
WVU Healthcare Ruby Memorial Suspended
Morgantown, West Virginia, United States, 26506-9180
United States, Wisconsin
University of Wisconsin Suspended
Madison, Wisconsin, United States, 53792
Aurora St. Luke's Medical Center Withdrawn
Milwaukee, Wisconsin, United States, 53215
Froedtert Hospital Suspended
Milwaukee, Wisconsin, United States, 53226
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    
Other Study ID Numbers: AAAR4607
1U01NS095869-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To share IPD of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
Supporting Materials: Study Protocol
Time Frame: As per NIH/NINDS requirements.
Access Criteria: All items required by NIH/NINDS will be publicly shared.

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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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Heart Diseases
Stroke
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