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

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apixaban
Aspirin
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Atrial Cardiopathy, Cryptogenic stroke, Ischemic stroke, Apixaban, Aspirin

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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:

  • History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization.
  • Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve.
  • Need for antiplatelet agent, such as aspirin or clopidogrel
  • History of spontaneous intracranial hemorrhage.
  • Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion.
  • Active hepatitis or hepatic insufficiency with Child-Pugh score B or C.
  • 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.

Sites / Locations

  • University of Alabama
  • University of South Alabama University Hospital
  • Chandler Regional Medical Center Chandler, AZ
  • St. Joseph's Hospital and Medical Center
  • Banner University Medical Center - Tucson
  • Mercy San Juan Medical Center (Dignity Health)
  • Eden Medical Center
  • Rancho Los Amigos National Rehabilitation Center
  • Fountain Valley Regional Hospital and Medical Center
  • Community Regional Medical Center
  • UCSD Health La Jolla
  • Sharp Grossmont Hospital
  • Long Beach Memorial Medical Center
  • Los Alamitos Medical Center
  • Kaiser Permanente
  • Keck Hospital Of USC
  • Los Angeles County- USC Medical Center
  • VA Greater Los Angeles - West LA VA Medical Center
  • Ronald Reagan UCLA Medical Center
  • UC Irvine Medical Center
  • Sutter Medical Center
  • Salinas Valley Memorial Hospital
  • Scripps Mercy
  • UCSD Medical Center - Hillcrest Hospital
  • Kaiser Permanent San Diego Medical Center
  • Sharp Memorial Hospital
  • San Francisco General
  • UCSF Medical Center
  • Good Samaritan
  • Stanford University Medical Center
  • Swedish Medical Center
  • St. Mary's Medical Center
  • St. Vincent's Medical Center
  • Hartford Hospital
  • Yale New Haven Hospital
  • Christiana Hospital
  • Med-star Georgetown Univ.
  • Medstar Washington
  • Boca Raton Regional Hospital
  • UF Health Shands
  • Baptist Medical Center Jacksonville
  • Mayo Clinic
  • Jackson Memorial
  • Univ. Miami Hospital
  • Baptist Hospital of Miami
  • Intercoastal Medical Group - Hyde Park
  • Tampa General
  • Emory University
  • Grady Memorial
  • The Queen's Medical Center
  • Northwestern Memorial Hospital
  • Rush University
  • University of Illinois
  • University of Chicago Medical Center
  • OSF St. Francis Medical Center
  • Southern Illinois University Memorial Medical Center
  • St. John's Hospital (Prairie Research)
  • Central DuPage Hospital
  • Multi-Specialty - Methodist Plaza/Unity Point
  • University of Iowa
  • University of Kansas
  • Baptist Health Lexington
  • University of Kentucky
  • University of Louisville Hospital
  • Ochsner Medical Center
  • Eastern Maine Medical Center
  • University of Maryland Medical Center
  • Tufts Medical Center
  • Massachusetts General Hospital
  • Boston Medical Center
  • Beth Israel Deaconess Medical
  • Brigham & Womens Hospital
  • Lahey Hospital & Medical Center
  • U Mass Memorial Medical Center
  • University of Michigan University Hospital
  • VA Ann Arbor Healthcare System
  • Detroit Receiving Hospital
  • Henry Ford Hospital
  • McLaren Flint
  • Mercy Health St. Mary's
  • Spectrum Health
  • McLaren Macomb, Mount Clemens, MI
  • McLaren Northern Michigan
  • Abbott Northwestern Hospital
  • Hennepin County
  • Univ. of Minnesota
  • Mayo Clinic
  • Regions Hospital, St. Paul
  • United Hospital
  • University of Mississippi Medical Center
  • Saint Luke's Hospital of Kansas City
  • St. Louis University Hospital
  • Barnes Jewish Hospital
  • Cox Medical Center South
  • CHI Health Immanuel
  • University of Nebraska
  • Cooper University Hospital,
  • Robert Wood Johnson
  • Capital Health Medical Center Hopewell
  • Univ. New Mexico
  • Montefiore Medical Center
  • Kings County Hospital
  • New York Presbyterian - Brooklyn Methodist Hospital
  • Maimonides Medical Center
  • NYU Langone Hospital - Brooklyn
  • Mount Sinai Beth Israel Brooklyn
  • Buffalo General Medical Center
  • North Shore University Hospital
  • NYU Langone
  • Mount Sinai West
  • Columbia University Medical Center
  • Weill Cornell Medicine
  • Lenox Hill Hospital
  • Strong Memorial Hospital
  • Moses H. Cone Memorial Hospital
  • Wake Forest Baptist Medical Center
  • Sanford Medical Center Fargo
  • Akron General Medical Center
  • University of Cincinnati
  • Louis Stokes VA Medical Center
  • UH Cleveland Medical Center
  • MetroHealth Medical Center
  • Cleveland Clinic
  • OSU Wexner
  • Ohio Health Riverside - Riverside Methodist Hospital
  • Miami Valley Hospita
  • Mercy St Vincent Medical Center
  • OU Medical Center Oklahoma
  • Legacy Emanuel
  • Oregon Health and Sciences
  • Lehigh Valley Hospital
  • UPMC Altoona
  • Lancaster General Hospital
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University Hospital
  • Temple University
  • Allegheny General Hospital
  • UPMC Presbyterian
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Prisma Health Richland Hospital (formerly Palmetto Health)
  • Prisma Health Greenville Memorial Hospital
  • Methodist University Hospital
  • Vanderbilt
  • UT Southwestern Medical Center
  • Valley Bapist
  • Baylor College College of Medicine
  • Houston Methodist Hospital
  • Memorial Hermann Texas Medical Center
  • Univ of Texas Health Science Center San Antonio
  • Scott & White Memorial Hospital - Temple
  • Memorial Hermann The Woodlands Hospital
  • Intermountain Medical Center
  • Utah Valley Regional Medical Center
  • Univ of Utah
  • George E Whalen VA
  • UVA Medical Center
  • Bon Secours St. Mary's Hospital
  • Providence St. Peter Hospital
  • Harborview Medical Center
  • Puget Sound VA
  • Swedish Medical Center - Cherry Hill Campus
  • WVU Healthcare Ruby Memorial
  • University of Wisconsin
  • Froedtert Hospital
  • University of Calgary - Foothills Medical Centre
  • University of Alberta Hospital
  • Neurologic Research Center
  • Kelowna General Hospital
  • Vancouver General Hospital
  • Brandon Regional Health Center
  • Hamilton General Hospital
  • Kingston General Hospital
  • London Health Sciences Center
  • Sunnybrook Health Sciences Center
  • Enfant-Jesus Hospital
  • Royal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active agent: Apixaban

Active control: Aspirin

Arm Description

Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban

Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin

Outcomes

Primary Outcome Measures

Incidence of recurrent stroke
Recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type)

Secondary Outcome Measures

Incidence of recurrent ischemic stroke or systemic embolism
Secondary efficacy outcome A
Incidence of recurrent stroke of any type plus death from any cause
Secondary efficacy outcome B
Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke).
Primary safety outcome A
Incidence of major hemorrhage other than intracranial hemorrhage
Primary safety outcome B
Incidence of death from any cause
Secondary safety outcome

Full Information

First Posted
June 16, 2017
Last Updated
June 6, 2023
Sponsor
Columbia University
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
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1. Study Identification

Unique Protocol Identification Number
NCT03192215
Brief Title
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Acronym
ARCADIA
Official Title
AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
The DSMB halted the trial prematurely due to futility without any safety concerns.
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
April 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
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

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Atrial Cardiopathy, Cryptogenic stroke, Ischemic stroke, Apixaban, Aspirin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
1015 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active agent: Apixaban
Arm Type
Experimental
Arm Description
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Apixaban
Arm Title
Active control: Aspirin
Arm Type
Active Comparator
Arm Description
Patients with a recent embolic stroke of undetermined source (ESUS) and evidence of atrial cardiopathy will receive Aspirin
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin Tablet
Intervention Description
Aspirin 81 mg by mouth once daily.
Primary Outcome Measure Information:
Title
Incidence of recurrent stroke
Description
Recurrent stroke of any type (ischemic, hemorrhagic, or of unclear type)
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Incidence of recurrent ischemic stroke or systemic embolism
Description
Secondary efficacy outcome A
Time Frame
Up to 7 years
Title
Incidence of recurrent stroke of any type plus death from any cause
Description
Secondary efficacy outcome B
Time Frame
Up to 7 years
Title
Incidence of symptomatic intracranial hemorrhage (including symptomatic hemorrhagic transformation of an ischemic stroke).
Description
Primary safety outcome A
Time Frame
Up to 7 years
Title
Incidence of major hemorrhage other than intracranial hemorrhage
Description
Primary safety outcome B
Time Frame
Up to 7 years
Title
Incidence of death from any cause
Description
Secondary safety outcome
Time Frame
Up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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: History of atrial fibrillation (AF), AF on 12-lead ECG, or any AF of any duration during heart-rhythm monitoring prior to randomization. Clear indication for treatment-dose anticoagulant therapy, such as venous thromboembolism or a mechanical heart valve. Need for antiplatelet agent, such as aspirin or clopidogrel History of spontaneous intracranial hemorrhage. Chronic kidney disease with serum creatinine ≥2.5 mg/dL.For Canadian sites only, estimated creatinine clearance (eCrCl) <15 mL/min is also an exclusion criterion. Active hepatitis or hepatic insufficiency with Child-Pugh score B or C. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randolph S Marshall, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of South Alabama University Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Chandler Regional Medical Center Chandler, AZ
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Mercy San Juan Medical Center (Dignity Health)
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Eden Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
Fountain Valley Regional Hospital and Medical Center
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
UCSD Health La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sharp Grossmont Hospital
City
La Mesa
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Los Alamitos Medical Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Kaiser Permanente
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Keck Hospital Of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Los Angeles County- USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
VA Greater Los Angeles - West LA VA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sutter Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Salinas Valley Memorial Hospital
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
Scripps Mercy
City
San Diego
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
UCSD Medical Center - Hillcrest Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Kaiser Permanent San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
San Francisco General
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Good Samaritan
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
St. Mary's Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
St. Vincent's Medical Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Med-star Georgetown Univ.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Medstar Washington
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
UF Health Shands
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Baptist Medical Center Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Jackson Memorial
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Univ. Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Intercoastal Medical Group - Hyde Park
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tampa General
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Memorial
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
The Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Southern Illinois University Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
St. John's Hospital (Prairie Research)
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Multi-Specialty - Methodist Plaza/Unity Point
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Brigham & Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
20115
Country
United States
Facility Name
Lahey Hospital & Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
U Mass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
McLaren Flint
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Mercy Health St. Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
McLaren Macomb, Mount Clemens, MI
City
Mount Clemens
State/Province
Michigan
ZIP/Postal Code
48043
Country
United States
Facility Name
McLaren Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Univ. of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Regions Hospital, St. Paul
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CHI Health Immanuel
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Cooper University Hospital,
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Capital Health Medical Center Hopewell
City
Pennington
State/Province
New Jersey
ZIP/Postal Code
08534
Country
United States
Facility Name
Univ. New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Kings County Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
New York Presbyterian - Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215-3609
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
NYU Langone Hospital - Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11220
Country
United States
Facility Name
Mount Sinai Beth Israel Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States
Facility Name
Buffalo General Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Moses H. Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Medical Center Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Louis Stokes VA Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
UH Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OSU Wexner
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio Health Riverside - Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Miami Valley Hospita
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Mercy St Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
OU Medical Center Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Legacy Emanuel
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health and Sciences
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
UPMC Altoona
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health Richland Hospital (formerly Palmetto Health)
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Valley Bapist
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Baylor College College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Texas Health Science Center San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott & White Memorial Hospital - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Memorial Hermann The Woodlands Hospital
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Utah Valley Regional Medical Center
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Univ of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
George E Whalen VA
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
UVA Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Bon Secours St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Providence St. Peter Hospital
City
Olympia
State/Province
Washington
ZIP/Postal Code
98506
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Puget Sound VA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Swedish Medical Center - Cherry Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
WVU Healthcare Ruby Memorial
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9180
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Calgary - Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Neurologic Research Center
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1J 0N9
Country
Canada
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Brandon Regional Health Center
City
Brandon
State/Province
Manitoba
ZIP/Postal Code
R7A 2B3
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L2V7
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Enfant-Jesus Hospital
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4-65543
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N0W8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
To share individual participant data (IPD) of baseline characteristics, follow up, outcomes, etc. based on NIH/NINDS requirements.
IPD Sharing Time Frame
As per NIH/NINDS requirements.
IPD Sharing Access Criteria
All items required by NIH/NINDS will be publicly shared.
Citations:
PubMed Identifier
26786114
Citation
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.
Results Reference
background
PubMed Identifier
26187229
Citation
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.
Results Reference
background
PubMed Identifier
26021638
Citation
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.
Results Reference
background
PubMed Identifier
25908460
Citation
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.
Results Reference
background
PubMed Identifier
23339958
Citation
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.
Results Reference
background
Links:
URL
https://www.nihstrokenet.org/trials/arcadia/home
Description
NIH/NINDS StrokeNet Prevention trials website
URL
https://youtu.be/YIneZ4n-xXE
Description
ARCADIA Trial Video

Learn more about this trial

AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

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