AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke



Status:Recruiting
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:45 - Any
Updated:3/21/2019
Start Date:January 19, 2018
End Date:April 30, 2022
Contact:Mitchell SV Elkind, MD
Email:mse13@cumc.columbia.edu
Phone:212 305-1710

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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.

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.

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.
We found this trial at
125
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Enrique Leira, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Steve Feske, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Kathryn Kirchoff-Torres, MD
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Dolora Wisco, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Ben Miller, MD
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Scott Kasner, MD
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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2215 Fuller Road
Ann Arbor, Michigan 48109
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Ann Arbor, Michigan 48109
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80 Jesse Hill Junior Drive Southeast
Atlanta, Georgia 30303
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Birmingham, Alabama 35294
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Boston, Massachusetts 02115
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330 Brookline Avenue
Boston, Massachusetts 02215
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Boston, Massachusetts 02118
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263 7th Avenue
Brooklyn, New York 11215
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4802 10th Ave
Brooklyn, New York 11219
(718) 283-6000
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Buffalo, New York 14203
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171 Ashley Avenue
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843-792-1414
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Chicago, Illinois 60612
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251 E Huron St
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1200 West Harrison Stree
Chicago, Illinois 60607
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2600 Clifton Ave
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11100 Euclid Avenue
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Columbia, South Carolina 29203
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410 West 10th Avenue
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2201 Inwood Rd
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Davenport, Iowa 52803
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Detroit, Michigan 48202
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
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501 E. Hampden Ave.
Englewood, Colorado 80113
303-788-5000
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
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Flint, Michigan 48532
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Fresno, California 93721
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2101 Pease Street
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7789 Southwest Freeway
Houston, Texas 77074
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6550 Fannin St
Houston, Texas 77030
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1924 Alcoa Highway
Knoxville, Tennessee 37916
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9300 Campus Point Drive
La Jolla, California 92037
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Lexington, Kentucky
859) 257-9000
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Long Beach, California 90801
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1983 Marengo St
Los Angeles, California 90033
(323) 226-2622
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530 S Jackson St
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502-562-3226
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1685 Highland Avenue
Madison, Wisconsin 53792
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Miami, Florida 33136
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1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
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1201 Northwest 16th Street
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8900 N Kendall Dr
Miami, Florida 33176
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Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55415
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1 Medical Center Drive
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5121 S Cottonwood St
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20 York St, N20 York St,
New Haven, Connecticut 06520
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1514 Jefferson Hwy.
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630 W 168th St
New York, New York
212-305-2862
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700 Northeast 13th Street
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703 Main Street
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1801 N Broad St
Philadelphia, Pennsylvania 19122
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350 W Thomas Rd
Phoenix, Arizona 85013
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2801 N Gantenbein Ave
Portland, Oregon 97227
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333 Smith Ave
Saint Paul, Minnesota 55102
(651) 241-8000
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Saint Paul, Minnesota 55101
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500 Foothill Drive
Salt Lake City, Utah 84148
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San Antonio, Texas 78229
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435 H Street
San Diego, California 91910
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200 West Arbor Drive
San Diego, California 92103
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