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
Arm | Description | Assigned 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). |
|
Placebo Comparator Aspirin |
Aspirin dose will be 81 mg tablet once daily. |
|
Recruiting Locations
Birmingham 4049979, Alabama 4829764 35294
Angela Shapshak, MD
Mobile 4076598, Alabama 4829764 36604
Taha Nisar, MD
Phoenix 5308655, Arizona 5551752 85013
Supreet Kaur, MD
Tucson 5318313, Arizona 5551752 85719
Firas Kaddouh, MD
Carmichael 5334336, California 5332921 95608
Lucian Maidan
Colton 5338783, California 5332921 92324
Dan Miulli, MD
Fontana 5349755, California 5332921 92335
Vaninder Chhabra
Fullerton 5351247, California 5332921 92835
Harry Peled, MD
Los Alamitos 5368304, California 5332921 90720
Nirav Patel, MD
Los Angeles 5368361, California 5332921 90027
Harsimran Brara, MD
Los Angeles 5368361, California 5332921 90048
Konrad Schlick, MD
Los Angeles 5368361, California 5332921 90095
Latisha Sharma, MD
Modesto 5373900, California 5332921 95350
James Jaffe, MD
Orange 5379513, California 5332921 92868
Wengui Yu, MD
Palm Springs 5380668, California 5332921 92262
Kevin Attenhofer, MD
Redwood City 5386834, California 5332921 94063
Sheila Chan, MD
Sacramento 5389489, California 5332921 95817
Kwan Ng, MD
Sacramento 5389489, California 5332921 95825
Yekaterina Axelrod, MD
San Francisco 5391959, California 5332921 94110
Claude Hemphill, MD
Santa Barbara 5392952, California 5332921 93105
Brian Walcott, MD
Stanford 5398563, California 5332921 94304
Chitra Venkat, MD
Whittier 5409059, California 5332921 90602
Gautam Ganguly, MD
Aurora 5412347, Colorado 5417618 80045
Sharon Poisson, MD
Hartford 4835797, Connecticut 4831725 06102
Mark Alberts, MD
New Haven 4839366, Connecticut 4831725 06511
Guido Falcone, MD
Wilmington 4145381, Delaware 4142224 28403
James McKinney, MD
Washington D.C. 4140963, District of Columbia 4138106 20007
Douglas Mayson, MD
Washington D.C. 4140963, District of Columbia 4138106 20037
Fernando Mayor Basto, MD
Clearwater 4151316, Florida 4155751 33756
Ajay Arora, MD
Jacksonville 4160021, Florida 4155751 32209
Kimberly McPhearson, MD
Miami 4164138, Florida 4155751 33136
Sebastian Koch
Pensacola 4168228, Florida 4155751 32504
Terry Neill, MD
Port Saint Lucie 4169171, Florida 4155751 34987
Marc Babi, MD
Tampa 4174757, Florida 4155751 33606
Swetha Renati, MD
Tampa 4174757, Florida 4155751 33607
Abilash Haridas, MD
Atlanta 4180439, Georgia 4197000 30303
Daniel Schachter, MD
Atlanta 4180439, Georgia 4197000 30322
Fadi Nahab, MD
Augusta 4180531, Georgia 4197000 30912
Fenwick Nichols, MD
Marietta 4207783, Georgia 4197000 30060
Christopher Horn, MD
Honolulu 5856195, Hawaii 5855797 96813
Kazuma Nakagawa, MD
Boise 5586437, Idaho 5596512 83706
Lukas Clark, MD
Arlington Heights 4883555, Illinois 4896861 60005
Mohammad Anadani, MD
Chicago 4887398, Illinois 4896861 60612
Rima Dafer, MD
Chicago 4887398, Illinois 4896861 60612
Ali Alaraj, MD
Chicago 4887398, Illinois 4896861 60637
Elisheva Coleman, MD
Chicago 4887398, Illinois 4896861 60637
Rachel Mehendale, MD
Evanston 4891382, Illinois 4896861 60201
Mohammad Anadani, MD
Maywood 4901514, Illinois 4896861 60153
Sarkis Morales-Vidal, MD
Peoria 4905687, Illinois 4896861 61637
Arun Talkad
Winfield 4916826, Illinois 4896861 60190
Dhruvil Pandya, MD
Indianapolis 4259418, Indiana 4921868 46202
Lisa Nobel, MD
Iowa City 4862034, Iowa 4862182 52242
Amir Shaban, MD
Kansas City 4273837, Kansas 4273857 66160
Kyle Carpenter, MD
Lexington 4297983, Kentucky 6254925 40503
Murali Kolikonda, MD
Lexington 4297983, Kentucky 6254925 40536
Suhas Gangadhara, MD
Louisville 4299276, Kentucky 6254925 40202
Isaac Abecassis, MD
New Orleans 4335045, Louisiana 4331987 70121
Richard Zweifler
Portland 4975802, Maine 4971068 04102
Teresa May, MD
Boston 4930956, Massachusetts 6254926 02111
Emiliya Melkumova, MD
Boston 4930956, Massachusetts 6254926 02114
Mariel Kozberg, MD
Boston 4930956, Massachusetts 6254926 02118
Steven Feske, MD
Boston 4930956, Massachusetts 6254926 02215
Magdy Selim, MD
Burlington 4931737, Massachusetts 6254926 01805
Colin James Culbertson, MD
Springfield 4951788, Massachusetts 6254926 01199
Gottfried Schlaug, MD
Worcester 4956184, Massachusetts 6254926 01655
Majaz Moonis, MD
Grand Rapids 4994358, Michigan 5001836 49503
Muhammad Farooq, MD
Mount Clemens 5002656, Michigan 5001836 48043
Bharath Naravetla, MD
Traverse City 5012495, Michigan 5001836 49684
Ramiro Castro-Apolo, MD
Minneapolis 5037649, Minnesota 5037779 55407
Ganesh Asaithambi, MD
Minneapolis 5037649, Minnesota 5037779 55455
Oladi Bentho, MD
Saint Cloud 5044407, Minnesota 5037779 56303
Muhammad Fareed Suri, MD
Saint Paul 5045360, Minnesota 5037779 55101
Darwin Ramirez-Abreu, MD
Columbia 4381982, Missouri 4398678 65212
Farhan Siddiq, MD
Springfield 4409896, Missouri 4398678 65804
Brenton Coger, MD
Springfield 4409896, Missouri 4398678 65807
Benjamin Lisle, MD
St Louis 4407066, Missouri 4398678 63110
Yan Wang, MD
St Louis 4407066, Missouri 4398678 63128
Venkat Chintapally-Rao, MD
St Louis 4407066, Missouri 4398678 63141
William Logan, MD
Omaha 5074472, Nebraska 5073708 68105
Pierre Fayad, MD
Hackensack 5098706, New Jersey 5101760 07601
Kaitlin Reilly-Kit, MD
Livingston 5100572, New Jersey 5101760 07052
Steven Shapiro, MD
Summit 5105127, New Jersey 5101760 07901
John Hanna, MD
Albuquerque 5454711, New Mexico 5481136 87106
Tarun Girotra, MD
Brooklyn 5110302, New York 5128638 11203
Susan Law, MD
Brooklyn 5110302, New York 5128638 11220
Jennifer Frontera
Elmhurst 5116495, New York 5128638 11373
Hazem Shoirah, MD
Manhasset 5125766, New York 5128638 11030
Rohan Arora, MD
New York 5128581, New York 5128638 10019
Neha Dangayach, MD
New York 5128581, New York 5128638 10029
Neha Dangayach, MD
New York 5128581, New York 5128638 10032
Imama Naqvi, MD
New York 5128581, New York 5128638 10065
Hooman Kamel, MD
Poughkeepsie 5132143, New York 5128638 12601
Paul Wright, MD
Rochester 5134086, New York 5128638 14642
Curtis Benesch, MD
Stony Brook 5139865, New York 5128638 11794
Jason Mathew, MD
Syracuse 5140405, New York 5128638 13210
Julius-Gene Latorre, MD
The Bronx 5110266, New York 5128638 10467
Kathryn Kirchoff-Torres, MD
Valhalla 5142090, New York 5128638 10595
Stephan Mayer, MD
Chapel Hill 4460162, North Carolina 4482348 27514
Julia Carlson, MD
Charlotte 4460243, North Carolina 4482348 28204
Melanie Greenway, MD
Durham 4464368, North Carolina 4482348 27710
Dylan Ryan, MD
Greensboro 4469146, North Carolina 4482348 27401
Pramod Sethi, MD
Greenville 4469160, North Carolina 4482348 27834
Shailesh Male, MD
Winston-Salem 4499612, North Carolina 4482348 27103
Mitchell Hargis, MD
Winston-Salem 4499612, North Carolina 4482348 27157
Stacey Wolfe, MD
Akron 5145476, Ohio 5165418 44307
Ahmed Itrat, MD
Cincinnati 4508722, Ohio 5165418 45219
Rob Stanton, MD
Cincinnati 4508722, Ohio 5165418 45220
Chengyuan Feng, MD
Cleveland 5150529, Ohio 5165418 44106
Abhishek Ray, MD
Cleveland 5150529, Ohio 5165418 44109
Agnieszka Ardelt, MD
Cleveland 5150529, Ohio 5165418 44195
Blake Buletko
Columbus 4509177, Ohio 5165418 43210
Yousef Hannawi, MD
Columbus 4509177, Ohio 5165418 43214
Vivek Rai, MD
Oklahoma City 4544349, Oklahoma 4544379 73104
Evgeny Sidorov
Oklahoma City 4544349, Oklahoma 4544379 73120
Jeffrey Craig, MD
Tulsa 4553433, Oklahoma 4544379 74104
Rahul Rahangdale, MD
Tulsa 4553433, Oklahoma 4544379 74104
Rahul Rahangdale, MD
Portland 5746545, Oregon 5744337 92739
Wayne Clark
Portland 5746545, Oregon 5744337 97213
John Zurasky
Springfield 5754005, Oregon 5744337 97477
Mariam Tsikvadze, MD
Abington 5177773, Pennsylvania 6254927 19001
Larami MacKenzie, MD
Hershey 5193342, Pennsylvania 6254927 17033
Nandakumar Nagaraja, MD
Philadelphia 4560349, Pennsylvania 6254927 19104
Aaron Rothstein, MD
Philadelphia 4560349, Pennsylvania 6254927 19140
Paul Katz, MD
Pittsburgh 5206379, Pennsylvania 6254927 15213
Marcelo Rocha
Charleston 4574324, South Carolina 4597040 29425
Christine Holmstedt, MD
Greenville 4580543, South Carolina 4597040 29605
Sanjeev Sivakumar, MD
Sioux Falls 5231851, South Dakota 5769223 57108
Jonathon Cooke, MD
Knoxville 4634946, Tennessee 4662168 37916
S. Arthur Moore, MD
Memphis 4641239, Tennessee 4662168 38104
Balaji Krishnaiah, MD
Memphis 4641239, Tennessee 4662168 38120
Neha Kumar, MD
Nashville 4644585, Tennessee 4662168 37232
Deborah Kerrigan, MD
Houston 4699066, Texas 4736286 77030
Britz Britz, MD
Houston 4699066, Texas 4736286 77030
Andrew Barreto, MD
San Antonio 4726206, Texas 4736286 78229
Reza Behrouz, MD
Salt Lake City 5780993, Utah 5549030 84112
Nabeel Chauhan, MD
Burlington 5234372, Vermont 5242283 05401
Chris Commichau
Charlottesville 4752031, Virginia 6254928 22908
Brad Worral, MD
Falls Church 4758390, Virginia 6254928 22042
Saqib Chaudhry, MD
Richmond 4781708, Virginia 6254928 23226
Amandeep Sangha, MD
Richmond 4781708, Virginia 6254928 23298
Shraddha Mainali, MD
Seattle 5809844, Washington 5815135 98104
David Tirschwell, MD
Morgantown 4815352, West Virginia 4826850 26506
Amelia Adcock, MD
Milwaukee 5263045, Wisconsin 5279468 53226
Hatim Attar, MD
More Details
- NCT ID
- NCT03907046
- Status
- Recruiting
- Sponsor
- Yale University
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.