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 |
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.
- 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.
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
sites
800 Washington St
Boston, Massachusetts 02111
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Emiliya Melkumova, MD
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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201 Dowman Dr
Atlanta, Georgia 30303
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Fadi Nahab, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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75 Francis street
Boston, Massachusetts 02115
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
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
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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101 Jessup Hall
Iowa City, Iowa 52242
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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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
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Scott Kasner, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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201 Presidents Circle
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Peter Hannon, MD
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
Principal Investigator: Atif Zafar, MD
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
(610) 402-8000
Principal Investigator: Hussam A Yacoub, MD
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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2215 Fuller Road
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Principal Investigator: James Burke, MD
Phone: 734-764-5871
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Ann Arbor, Michigan 48109
Principal Investigator: James Burke, MD
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80 Jesse Hill Junior Drive Southeast
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Principal Investigator: Nicolas Bianchi, MD
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330 Brookline Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Principal Investigator: Sandeep Kumar, MD
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263 7th Avenue
Brooklyn, New York 11215
Brooklyn, New York 11215
Principal Investigator: Jeffrey Benjamin, MD
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4802 10th Ave
Brooklyn, New York 11219
Brooklyn, New York 11219
(718) 283-6000
Principal Investigator: Steven Rudolph, MD
Maimonides Medical Center At 103 years old, Maimonides Medical Center remains a vital and thriving...
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Castro Valley, California 94546
Principal Investigator: Peter R. Adamczyk, MD
Phone: 510-727-8267
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Chirantan Banerjee, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Brad Worrall, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Fan Caprio, MD
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1200 West Harrison Stree
Chicago, Illinois 60607
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Fernando Testai, MD
Univ of Illinois A major research university in the heart of one of the world's...
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2600 Clifton Ave
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Dawn Kleindorfer, MD
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland, Ohio 44106
Principal Investigator: Svetlana Pundik, MD
Phone: 877-838-8262
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2500 Metrohealth Dr
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-7800
Principal Investigator: Joseph Hanna, MD
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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11100 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Principal Investigator: Sophia Sundararajan, MD
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Columbus, Ohio 43214
Principal Investigator: Nora Vora, MD
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2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Ty Shang, MD
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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2799 W Grand Blvd
Detroit, Michigan 48202
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Angelos Katramados, MD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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501 E. Hampden Ave.
Englewood, Colorado 80113
Englewood, Colorado 80113
303-788-5000
Principal Investigator: Alicia Bennett, MD
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801 Broadway
Fargo, North Dakota 58102
Fargo, North Dakota 58102
(701) 234-6175
Principal Investigator: Michael Manchak, MD
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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Fresno, California 93721
Principal Investigator: William Likosky, MD
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Grand Rapids, Michigan 49503
Principal Investigator: Christopher Goshgarian, MD
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Greenville, South Carolina 29615
Principal Investigator: Paulo Zortea, MD
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7789 Southwest Freeway
Houston, Texas 77074
Houston, Texas 77074
Principal Investigator: Anajail Sharrief, MD
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6550 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 790-3311
Principal Investigator: Vivek Misra, MD
Houston Methodist Hospital Houston Methodist is comprised of a leading academic medical center in the...
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1924 Alcoa Highway
Knoxville, Tennessee 37916
Knoxville, Tennessee 37916
Principal Investigator: Shamir Haji, MD
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9300 Campus Point Drive
La Jolla, California 92037
La Jolla, California 92037
Principal Investigator: Royya Modir, MD
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Lexington, Kentucky
859) 257-9000
Principal Investigator: L. Creed Pettigrew, MD, MPH
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Long Beach, California 90801
Principal Investigator: Nima Ramezan-Arab, MD
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1983 Marengo St
Los Angeles, California 90033
Los Angeles, California 90033
(323) 226-2622
Principal Investigator: Nerses Sanossian, MD
Los Angeles County-USC Medical Center The origins of LAC+USC Medical Center date back to 1878,...
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Los Angeles, California 90073
Principal Investigator: Roi A Wallis, MD
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530 S Jackson St
Louisville, Kentucky 40202
Louisville, Kentucky 40202
502-562-3226
Principal Investigator: Tracy Ander, MD
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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1685 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Principal Investigator: Edward L. Bradbury, MD
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1400 NW 12th Ave
Miami, Florida 33136
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Erika T Marulanda-Londono, MD
University of Miami Hospital The University of Miami changed the face of modern health care...
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1201 Northwest 16th Street
Miami, Florida 33176
Miami, Florida 33176
Principal Investigator: Seemant Chaturvedi, MD
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8900 N Kendall Dr
Miami, Florida 33176
Miami, Florida 33176
(786) 596-1960
Principal Investigator: Felipe De Los Rios, MD
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
Milwaukee, Wisconsin 53215
414-649-6000
Principal Investigator: Rehan Sejjad, MD
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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1 Medical Center Drive
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
Principal Investigator: Avi Muhammad, MD
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5121 S Cottonwood St
Murray, Utah 84157
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Megan Donohue, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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20 York St, N20 York St,
New Haven, Connecticut 06520
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Reshma Narula, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
504-842-3000
Principal Investigator: Richard Zweifler, MD
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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630 W 168th St
New York, New York
New York, New York
212-305-2862
Principal Investigator: Eliza Miller, MD
Phone: 212-305-1710
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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700 Northeast 13th Street
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Principal Investigator: Evgeny Sidorov, MD
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703 Main Street
Paterson, New Jersey 07503
Paterson, New Jersey 07503
Principal Investigator: Oriana Cornett, MD
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1801 N Broad St
Philadelphia, Pennsylvania 19122
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Paul Katz, MD
Temple University Temple University is many things to many people. A place to pursue life's...
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350 W Thomas Rd
Phoenix, Arizona 85013
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Supreet Kaur, MD
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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2801 N Gantenbein Ave
Portland, Oregon 97227
Portland, Oregon 97227
Principal Investigator: Martin Gizzi, MD
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333 Smith Ave
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
(651) 241-8000
Principal Investigator: Ganesh Asaithambi, MD
United Hospital United Hospital is the largest hospital in the Twin Cities east metro area,...
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500 Foothill Drive
Salt Lake City, Utah 84148
Salt Lake City, Utah 84148
Principal Investigator: Jana Wold, MD
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7703 Floyd Curl Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
Principal Investigator: Reza Behrouz, MD
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200 West Arbor Drive
San Diego, California 92103
San Diego, California 92103
Principal Investigator: Royya Modir, MD
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