Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Purpose

Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.

Conditions

  • Intracerebral Hemorrhage
  • Atrial Fibrillation

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age at least 18 years - Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI - Can be randomized within 14-180 days after ICH onset - Non-valvular AF (defined as atrial fibrillation or atrial flutter), documented by electrocardiography or a physician-confirmed history of prior AF - Provision of signed and dated informed consent form by patient or legally authorized representative - For females of reproductive potential: use of highly effective contraception

Exclusion Criteria

  • Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor - History of earlier ICH within 12 months preceding index event - Active infective endocarditis - Clear indication for anticoagulant drugs (e.g., requires anticoagulation for deep vein thrombosis or pulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogrel for recent coronary stent). - Previous or planned left atrial appendage closure - Clinically significant bleeding diathesis - Serum creatinine ≥2.5 mg/dL - Active hepatitis or hepatic insufficiency with Child-Pugh score B or C - Anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10^9/L) that is chronic in the judgment of the investigator - Pregnant or breastfeeding - Known allergy to aspirin or apixaban - Concomitant participation in a competing trial - Considered by the investigator to have a condition that precludes safe or active participation in the trial - Persistent, uncontrolled systolic blood pressure (≥180 mm Hg) - ICH caused by an arteriovenous malformation (AVM) that has not yet been secured

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Apixaban
Apixaban dosing will be 5 mg tablet in morning and 5 mg tablet in evening. A reduced dose of 2.5 mg tablet in morning and 2.5 mg tablet in evening will be used if: (1) ≥2 of the following are present: age ≥80 years, body weight ≤60 kg, or serum creatinine 1.5-2.4 mg/dL, or (2) Patient is taking a strong CYP3A4/pGP inhibitor (e.g., ketoconazole, itraconazole, ritonavir, or clarithromycin).
  • Drug: Apixaban
    Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
    Other names:
    • Eliquis
Placebo Comparator
Aspirin
Aspirin dose will be 81 mg tablet once daily.
  • Drug: Aspirin
    Aspirin is an oral antiplatelet drug.

Recruiting Locations

University of Alabama Hospital
Birmingham 4049979, Alabama 4829764 35294
Contact:
Angela Shapshak, MD

University of South Alabama University Hospital
Mobile 4076598, Alabama 4829764 36604
Contact:
Taha Nisar, MD

St. Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013
Contact:
Supreet Kaur, MD

Banner University Medical Center
Tucson 5318313, Arizona 5551752 85719
Contact:
Firas Kaddouh, MD

Mercy San Juan Medical Center
Carmichael 5334336, California 5332921 95608
Contact:
Lucian Maidan

Arrowhead Regional Medical Center
Colton 5338783, California 5332921 92324
Contact:
Dan Miulli, MD

Kaiser Permanente Fontana Medical Center
Fontana 5349755, California 5332921 92335
Contact:
Vaninder Chhabra

St. Jude Medical Center
Fullerton 5351247, California 5332921 92835
Contact:
Harry Peled, MD

Los Alamitos Medical Center
Los Alamitos 5368304, California 5332921 90720
Contact:
Nirav Patel, MD

Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027
Contact:
Harsimran Brara, MD

Cedars-Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Contact:
Konrad Schlick, MD

Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90095
Contact:
Latisha Sharma, MD

Doctors Medical Center Modesto, Modesto, CA
Modesto 5373900, California 5332921 95350
Contact:
James Jaffe, MD

UC Irvine Medical Center
Orange 5379513, California 5332921 92868
Contact:
Wengui Yu, MD

Desert Regional Medical Center
Palm Springs 5380668, California 5332921 92262
Contact:
Kevin Attenhofer, MD

Kaiser Permanente Redwood City Medical Center, Redwood City, CA
Redwood City 5386834, California 5332921 94063
Contact:
Sheila Chan, MD

UC Davis Medical Center
Sacramento 5389489, California 5332921 95817
Contact:
Kwan Ng, MD

Kaiser Permanente Sacramento Medical Center
Sacramento 5389489, California 5332921 95825
Contact:
Yekaterina Axelrod, MD

San Francisco General Hospital
San Francisco 5391959, California 5332921 94110
Contact:
Claude Hemphill, MD

Santa Barbara Cottage Hospital
Santa Barbara 5392952, California 5332921 93105
Contact:
Brian Walcott, MD

Stanford University Medical Center
Stanford 5398563, California 5332921 94304
Contact:
Chitra Venkat, MD

PIH Health Hospital - Whittier
Whittier 5409059, California 5332921 90602
Contact:
Gautam Ganguly, MD

University of Colorado Hospital
Aurora 5412347, Colorado 5417618 80045
Contact:
Sharon Poisson, MD

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
Contact:
Mark Alberts, MD

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06511
Contact:
Guido Falcone, MD

New Hanover Regional Medical Center
Wilmington 4145381, Delaware 4142224 28403
Contact:
James McKinney, MD

MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007
Contact:
Douglas Mayson, MD

George Washington University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20037
Contact:
Fernando Mayor Basto, MD

Morton Plant Hospital
Clearwater 4151316, Florida 4155751 33756
Contact:
Ajay Arora, MD

UF Health Jacksonville
Jacksonville 4160021, Florida 4155751 32209
Contact:
Kimberly McPhearson, MD

Jackson Memorial Hospital
Miami 4164138, Florida 4155751 33136
Contact:
Sebastian Koch

Ascension Sacred Heart Pensacola
Pensacola 4168228, Florida 4155751 32504
Contact:
Terry Neill, MD

Cleveland Clinic Tradition Hospital
Port Saint Lucie 4169171, Florida 4155751 34987
Contact:
Marc Babi, MD

Tampa General Hospital
Tampa 4174757, Florida 4155751 33606
Contact:
Swetha Renati, MD

St. Joseph's Hospital
Tampa 4174757, Florida 4155751 33607
Contact:
Abilash Haridas, MD

Grady Memorial Hospital
Atlanta 4180439, Georgia 4197000 30303
Contact:
Daniel Schachter, MD

Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
Contact:
Fadi Nahab, MD

Augusta University Medical Center
Augusta 4180531, Georgia 4197000 30912
Contact:
Fenwick Nichols, MD

WellStar Kennestone Hospital
Marietta 4207783, Georgia 4197000 30060
Contact:
Christopher Horn, MD

The Queen's Medical Center
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Kazuma Nakagawa, MD

Saint Alphonsus Regional Medical Center - Boise
Boise 5586437, Idaho 5596512 83706
Contact:
Lukas Clark, MD

NCH Hospital, Arlington Heights
Arlington Heights 4883555, Illinois 4896861 60005
Contact:
Mohammad Anadani, MD

Rush University Medical Center
Chicago 4887398, Illinois 4896861 60612
Contact:
Rima Dafer, MD

University of Illinois Hospital
Chicago 4887398, Illinois 4896861 60612
Contact:
Ali Alaraj, MD

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Elisheva Coleman, MD

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
Contact:
Rachel Mehendale, MD

Evanston Hospital
Evanston 4891382, Illinois 4896861 60201
Contact:
Mohammad Anadani, MD

Loyola University Medical Center
Maywood 4901514, Illinois 4896861 60153
Contact:
Sarkis Morales-Vidal, MD

OSF St. Francis Medical Center
Peoria 4905687, Illinois 4896861 61637
Contact:
Arun Talkad

Central DuPage Hospital
Winfield 4916826, Illinois 4896861 60190
Contact:
Dhruvil Pandya, MD

IU Health Methodist Hospital
Indianapolis 4259418, Indiana 4921868 46202
Contact:
Lisa Nobel, MD

University of Iowa Medical Center
Iowa City 4862034, Iowa 4862182 52242
Contact:
Amir Shaban, MD

University of Kansas Hospital
Kansas City 4273837, Kansas 4273857 66160
Contact:
Kyle Carpenter, MD

Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503
Contact:
Murali Kolikonda, MD

University of Kentucky Hospital
Lexington 4297983, Kentucky 6254925 40536
Contact:
Suhas Gangadhara, MD

University of Louisville Hospital
Louisville 4299276, Kentucky 6254925 40202
Contact:
Isaac Abecassis, MD

Ochsner Medical Center - Main Campus
New Orleans 4335045, Louisiana 4331987 70121
Contact:
Richard Zweifler

Maine Medical Center
Portland 4975802, Maine 4971068 04102
Contact:
Teresa May, MD

Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Contact:
Emiliya Melkumova, MD

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Mariel Kozberg, MD

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Steven Feske, MD

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Magdy Selim, MD

Lahey Hospital & Medical Center
Burlington 4931737, Massachusetts 6254926 01805
Contact:
Colin James Culbertson, MD

Baystate Medical Center
Springfield 4951788, Massachusetts 6254926 01199
Contact:
Gottfried Schlaug, MD

UMass Memorial Medical Center
Worcester 4956184, Massachusetts 6254926 01655
Contact:
Majaz Moonis, MD

Trinity Health Saint Mary's
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Muhammad Farooq, MD

McLaren Macomb
Mount Clemens 5002656, Michigan 5001836 48043
Contact:
Bharath Naravetla, MD

Munson Medical Center
Traverse City 5012495, Michigan 5001836 49684
Contact:
Ramiro Castro-Apolo, MD

Abbott Northwestern Hospital
Minneapolis 5037649, Minnesota 5037779 55407
Contact:
Ganesh Asaithambi, MD

M Health Fairview University of Minnesota Medical Center
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Oladi Bentho, MD

St. Cloud Hospital
Saint Cloud 5044407, Minnesota 5037779 56303
Contact:
Muhammad Fareed Suri, MD

Regions Hospital
Saint Paul 5045360, Minnesota 5037779 55101
Contact:
Darwin Ramirez-Abreu, MD

University of Missouri Health Care
Columbia 4381982, Missouri 4398678 65212
Contact:
Farhan Siddiq, MD

Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Contact:
Brenton Coger, MD

Cox Medical Center South
Springfield 4409896, Missouri 4398678 65807
Contact:
Benjamin Lisle, MD

Barnes Jewish Hospital
St Louis 4407066, Missouri 4398678 63110
Contact:
Yan Wang, MD

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
Contact:
Venkat Chintapally-Rao, MD

Mercy Hospital St. Louis
St Louis 4407066, Missouri 4398678 63141
Contact:
William Logan, MD

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68105
Contact:
Pierre Fayad, MD

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Kaitlin Reilly-Kit, MD

Cooperman Barnabas Medical Center
Livingston 5100572, New Jersey 5101760 07052
Contact:
Steven Shapiro, MD

Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901
Contact:
John Hanna, MD

University of New Mexico Hospital
Albuquerque 5454711, New Mexico 5481136 87106
Contact:
Tarun Girotra, MD

Kings County Hospital Center
Brooklyn 5110302, New York 5128638 11203
Contact:
Susan Law, MD

NYU Langone Hospital - Brooklyn
Brooklyn 5110302, New York 5128638 11220
Contact:
Jennifer Frontera

NYC Health + Hospitals/Elmhurst
Elmhurst 5116495, New York 5128638 11373
Contact:
Hazem Shoirah, MD

North Shore University Hospital
Manhasset 5125766, New York 5128638 11030
Contact:
Rohan Arora, MD

Mount Sinai West
New York 5128581, New York 5128638 10019
Contact:
Neha Dangayach, MD

The Mount Sinai Hospital
New York 5128581, New York 5128638 10029
Contact:
Neha Dangayach, MD

NYP Columbia University Medical Center
New York 5128581, New York 5128638 10032
Contact:
Imama Naqvi, MD

NYP Weill Cornell Medical Center
New York 5128581, New York 5128638 10065
Contact:
Hooman Kamel, MD

Vassar Brothers Medical Center
Poughkeepsie 5132143, New York 5128638 12601
Contact:
Paul Wright, MD

Strong Memorial Hospital
Rochester 5134086, New York 5128638 14642
Contact:
Curtis Benesch, MD

Stony Brook University Hospital
Stony Brook 5139865, New York 5128638 11794
Contact:
Jason Mathew, MD

SUNY Upstate Medical University
Syracuse 5140405, New York 5128638 13210
Contact:
Julius-Gene Latorre, MD

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
Contact:
Kathryn Kirchoff-Torres, MD

Westchester Medical Center
Valhalla 5142090, New York 5128638 10595
Contact:
Stephan Mayer, MD

University of North Carolina Medical Center
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
Julia Carlson, MD

Presbyterian Medical Center
Charlotte 4460243, North Carolina 4482348 28204
Contact:
Melanie Greenway, MD

Duke University Hospital
Durham 4464368, North Carolina 4482348 27710
Contact:
Dylan Ryan, MD

Moses H. Cone Memorial Hospital
Greensboro 4469146, North Carolina 4482348 27401
Contact:
Pramod Sethi, MD

ECU Health Medical Center
Greenville 4469160, North Carolina 4482348 27834
Contact:
Shailesh Male, MD

Forsyth Medical Center
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Mitchell Hargis, MD

Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157
Contact:
Stacey Wolfe, MD

Cleveland Clinic Akron General
Akron 5145476, Ohio 5165418 44307
Contact:
Ahmed Itrat, MD

University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Rob Stanton, MD

Good Samaritan Hospital
Cincinnati 4508722, Ohio 5165418 45220
Contact:
Chengyuan Feng, MD

UH Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Abhishek Ray, MD

MetroHealth Medical Center
Cleveland 5150529, Ohio 5165418 44109
Contact:
Agnieszka Ardelt, MD

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Blake Buletko

OSU Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Yousef Hannawi, MD

Riverside Methodist Hospital
Columbus 4509177, Ohio 5165418 43214
Contact:
Vivek Rai, MD

OU Medical Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Contact:
Evgeny Sidorov

Mercy Hospital Oklahoma City
Oklahoma City 4544349, Oklahoma 4544379 73120
Contact:
Jeffrey Craig, MD

Ascension St. John Medical Center
Tulsa 4553433, Oklahoma 4544379 74104
Contact:
Rahul Rahangdale, MD

St. John Medical Center
Tulsa 4553433, Oklahoma 4544379 74104
Contact:
Rahul Rahangdale, MD

Oregon Health & Science University Hospital
Portland 5746545, Oregon 5744337 92739
Contact:
Wayne Clark

Providence St. Vincent Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
John Zurasky

PeaceHealth Sacred Heart Medical Center - RiverBend
Springfield 5754005, Oregon 5744337 97477
Contact:
Mariam Tsikvadze, MD

Jefferson Abington Hospital
Abington 5177773, Pennsylvania 6254927 19001
Contact:
Larami MacKenzie, MD

Penn State Hershey Medical Center
Hershey 5193342, Pennsylvania 6254927 17033
Contact:
Nandakumar Nagaraja, MD

Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Aaron Rothstein, MD

Temple University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19140
Contact:
Paul Katz, MD

UPMC Presbyterian Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213
Contact:
Marcelo Rocha

Medical University of South Carolina University Hospital
Charleston 4574324, South Carolina 4597040 29425
Contact:
Christine Holmstedt, MD

Greenville Hospital System
Greenville 4580543, South Carolina 4597040 29605
Contact:
Sanjeev Sivakumar, MD

Avera Research Institute
Sioux Falls 5231851, South Dakota 5769223 57108
Contact:
Jonathon Cooke, MD

Fort Sanders Regional Medical Center
Knoxville 4634946, Tennessee 4662168 37916
Contact:
S. Arthur Moore, MD

Methodist University Hospital
Memphis 4641239, Tennessee 4662168 38104
Contact:
Balaji Krishnaiah, MD

Semmes Murphey Main Campus
Memphis 4641239, Tennessee 4662168 38120
Contact:
Neha Kumar, MD

Vanderbilt University Hospital
Nashville 4644585, Tennessee 4662168 37232
Contact:
Deborah Kerrigan, MD

Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
Contact:
Britz Britz, MD

Memorial Hermann Texas Medical Center
Houston 4699066, Texas 4736286 77030
Contact:
Andrew Barreto, MD

University of Texas Health Science Center San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Reza Behrouz, MD

University of Utah Healthcare
Salt Lake City 5780993, Utah 5549030 84112
Contact:
Nabeel Chauhan, MD

The University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
Contact:
Chris Commichau

UVA Medical Center
Charlottesville 4752031, Virginia 6254928 22908
Contact:
Brad Worral, MD

Inova Fairfax Hospital
Falls Church 4758390, Virginia 6254928 22042
Contact:
Saqib Chaudhry, MD

Bon Secours St. Mary's Hospital
Richmond 4781708, Virginia 6254928 23226
Contact:
Amandeep Sangha, MD

VCU Medical Center
Richmond 4781708, Virginia 6254928 23298
Contact:
Shraddha Mainali, MD

Harborview Medical Center
Seattle 5809844, Washington 5815135 98104
Contact:
David Tirschwell, MD

WVU Healthcare Ruby Memorial Hospital
Morgantown 4815352, West Virginia 4826850 26506
Contact:
Amelia Adcock, MD

Froedtert Hospital
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Hatim Attar, MD

More Details

NCT ID
NCT03907046
Status
Recruiting
Sponsor
Yale University

Study Contact

Kevin N Sheth, MD
443-615-4729
kevin.sheth@yale.edu

Detailed Description

ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH and non-valvular AF. Seven hundred patients will be enrolled over 3.5 years and followed for study outcomes for a minimum of 12 months and maximum of 36 months. The primary efficacy outcome is any stroke (hemorrhagic or ischemic) or death from any cause. The secondary efficacy outcome is the change in the modified Rankin Scale score. Recruitment will take place at sites coordinated through the NIH/NINDS StrokeNet.