Anticoagulation in ICH Survivors for Stroke Prevention and Recovery (ASPIRE)

March 20, 2024 updated by: Yale University

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Kevin N Sheth, MD
Phone Number: 443-615-4729
Email: kevin.sheth@yale.edu

Study Contact Backup

Name: Hooman Kamel, MD
Phone Number: 646-962-8284
Email: hok9010@med.cornell.edu

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Recruiting
    - University of Alabama Hospital
    - Contact:
      
      Angela Shapshak, MD
  - Mobile, Alabama, United States, 36604
    - Recruiting
    - University of South Alabama University Hospital
    - Contact:
      
      Taha Nisar, MD
- Arizona
  - Chandler, Arizona, United States, 85224
    - Withdrawn
    - Chandler Regional Medical Center
  - Tucson, Arizona, United States, 85719
    - Recruiting
    - Banner University Medical Center
    - Contact:
      
      Firas Kaddouh, MD
- Arkansas
  - Little Rock, Arkansas, United States, 77205
    - Withdrawn
    - UAMS Medical Center
- California
  - Carmichael, California, United States, 95608
    - Recruiting
    - Mercy San Juan Medical Center
    - Contact:
      
      Lucian Maidan
  - Castro Valley, California, United States, 94546
    - Withdrawn
    - Eden Medical Center, Castro Valley
  - Colton, California, United States, 92324
    - Recruiting
    - Arrowhead Regional Medical Center
    - Contact:
      
      Dan Miulli, MD
  - Downey, California, United States, 90242
    - Suspended
    - Rancho Los Amigos National Rehabilitation Center
  - Fontana, California, United States, 92335
    - Recruiting
    - Kaiser Permanente Fontana Medical Center
    - Contact:
      
      Vaninder Chhabra
  - Long Beach, California, United States, 90806
    - Withdrawn
    - Long Beach Memorial Medical Center
  - Los Alamitos, California, United States, 90720
    - Recruiting
    - Los Alamitos Medical Center
    - Contact:
      
      Nirav Patel, MD
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars-Sinai Medical Center
    - Contact:
      
      Konrad Schlick, MD
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Kaiser Permanente Los Angeles Medical Center
    - Contact:
      
      Harsimran Brara, MD
  - Los Angeles, California, United States, 90095
    - Recruiting
    - Ronald Reagan UCLA Medical Center
    - Contact:
      
      Latisha Sharma, MD
  - Modesto, California, United States, 95350
    - Recruiting
    - Doctors Medical Center Modesto, Modesto, CA
    - Contact:
      
      James Jaffe, MD
  - Newport Beach, California, United States, 92663
    - Withdrawn
    - Hoag Hospital Newport Beach
  - Orange, California, United States, 92868
    - Recruiting
    - UC Irvine Medical Center
    - Contact:
      
      Wengui Yu, MD
  - Palm Springs, California, United States, 92262
    - Recruiting
    - Desert Regional Medical Center
    - Contact:
      
      Kevin Attenhofer, MD
  - Pasadena, California, United States, 91105
    - Recruiting
    - Huntington Memorial Hospital
    - Contact:
      
      Arib Ohanian, MD
  - Redwood City, California, United States, 94063
    - Recruiting
    - Kaiser Permanente Redwood City Medical Center, Redwood City, CA
    - Contact:
      
      Sheila Chan, MD
  - Sacramento, California, United States, 95817
    - Recruiting
    - UC Davis Medical Center
    - Contact:
      
      Kwan Ng, MD
  - Sacramento, California, United States, 95825
    - Recruiting
    - Kaiser Permanente Sacramento Medical Center
    - Contact:
      
      Yekaterina Axelrod, MD
  - San Francisco, California, United States, 94110
    - Recruiting
    - San Francisco General Hospital
    - Contact:
      
      Claude Hemphill, MD
  - Stanford, California, United States, 94304
    - Recruiting
    - Stanford University Medical Center
    - Contact:
      
      Chitra Venkat, MD
  - Whittier, California, United States, 90602
    - Recruiting
    - PIH Health Hospital - Whittier
    - Contact:
      
      Gautam Ganguly, MD
- Colorado
  - Grand Junction, Colorado, United States, 81501
    - Withdrawn
    - St. Mary's Medical Center
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - Recruiting
    - Danbury Hospital
    - Contact:
      
      Charles Guardia, MD
  - Hartford, Connecticut, United States, 06102
    - Recruiting
    - Hartford Hospital
    - Contact:
      
      Mark Alberts, MD
  - New Haven, Connecticut, United States, 06511
    - Recruiting
    - Yale New Haven Hospital
    - Contact:
      
      Guido Falcone, MD
- Delaware
  - Wilmington, Delaware, United States, 28403
    - Recruiting
    - New Hanover Regional Medical Center
    - Contact:
      
      James McKinney, MD
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Recruiting
    - MedStar Georgetown University Hospital
    - Contact:
      
      Douglas Mayson, MD
  - Washington, District of Columbia, United States, 20010
    - Withdrawn
    - MedStar Washington Hospital Center
- Florida
  - Clearwater, Florida, United States, 33756
    - Recruiting
    - Morton Plant Hospital
    - Contact:
      
      Ajay Arora, MD
  - Jacksonville, Florida, United States, 32224
    - Terminated
    - Mayo Clinic
  - Miami, Florida, United States, 33136
    - Recruiting
    - Jackson Memorial Hospital
    - Contact:
      
      Sebastian Koch
  - Pensacola, Florida, United States, 32504
    - Recruiting
    - Ascension Sacred Heart Pensacola
    - Contact:
      
      Terry Neill, MD
  - Port Saint Lucie, Florida, United States, 34987
    - Recruiting
    - Cleveland Clinic Tradition Hospital
    - Contact:
      
      Marc Babi, MD
  - Tampa, Florida, United States, 33606
    - Recruiting
    - Tampa General Hospital
    - Contact:
      
      Swetha Renati, MD
  - Tampa, Florida, United States, 33607
    - Recruiting
    - St. Joseph's Hospital
    - Contact:
      
      Abilash Haridas, MD
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Recruiting
    - Grady Memorial Hospital
    - Contact:
      
      Daniel Schachter, MD
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory University Hospital
    - Contact:
      
      Fadi Nahab, MD
  - Augusta, Georgia, United States, 30912
    - Recruiting
    - Augusta University Medical Center
    - Contact:
      
      Fenwick Nichols, MD
  - Marietta, Georgia, United States, 30060
    - Recruiting
    - WellStar Kennestone Hospital
    - Contact:
      
      Christopher Horn, MD
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Recruiting
    - The Queen's Medical Center
    - Contact:
      
      Kazuma Nakagawa, MD
- Illinois
  - Arlington Heights, Illinois, United States, 60005
    - Withdrawn
    - NCH Hospital, Arlington Heights
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - Rush University Medical Center
    - Contact:
      
      Rima Dafer, MD
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - University of Chicago Medical Center
    - Contact:
      
      Elisheva Coleman, MD
  - Chicago, Illinois, United States, 60612
    - Recruiting
    - University of Illinois Hospital
    - Contact:
      
      Ali Alaraj, MD
  - Maywood, Illinois, United States, 60153
    - Recruiting
    - Loyola University Medical Center
    - Contact:
      
      Sarkis Morales-Vidal, MD
  - Peoria, Illinois, United States, 61637
    - Recruiting
    - OSF St. Francis Medical Center
    - Contact:
      
      Arun Talkad
  - Rockford, Illinois, United States, 61114
    - Withdrawn
    - Javon Bea Hospital - Riverside
  - Springfield, Illinois, United States, 62769
    - Withdrawn
    - St. John's Hospital
  - Winfield, Illinois, United States, 60190
    - Recruiting
    - Central DuPage Hospital
    - Contact:
      
      Dhruvil Pandya, MD
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa Hospitals & Clinics
    - Contact:
      
      Amir Shaban, MD
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Recruiting
    - University of Kansas Hospital
    - Contact:
      
      Kyle Carpenter, MD
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Recruiting
    - University of Kentucky Hospital
    - Contact:
      
      Suhas Gangadhara, MD
  - Louisville, Kentucky, United States, 40202
    - Withdrawn
    - University of Louisville Hospital
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Medical Center - Main Campus
    - Contact:
      
      Richard Zweifler
- Maine
  - Bangor, Maine, United States, 04401
    - Withdrawn
    - Eastern Maine Medical Center
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital
    - Contact:
      
      Mariel Kozberg, MD
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Beth Israel Deaconess Medical Center
    - Contact:
      
      Magdy Selim, MD
  - Boston, Massachusetts, United States, 02118
    - Recruiting
    - Boston Medical Center
    - Contact:
      
      Steven Feske, MD
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
    - Contact:
      
      Emiliya Melkumova, MD
  - Burlington, Massachusetts, United States, 01805
    - Recruiting
    - Lahey Hospital & Medical Center
    - Contact:
      
      Colin James Culbertson, MD
  - Springfield, Massachusetts, United States, 01199
    - Recruiting
    - Baystate Medical Center
    - Contact:
      
      Gottfried Schlaug, MD
  - Worcester, Massachusetts, United States, 01655
    - Recruiting
    - UMASS Memorial Medical Center
    - Contact:
      
      Majaz Moonis, MD
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan University Hospital
    - Contact:
      
      Aditya Pandey
  - Detroit, Michigan, United States, 48202
    - Withdrawn
    - Henry Ford Hospital
  - Flint, Michigan, United States, 48532
    - Recruiting
    - McLaren Flint
    - Contact:
      
      Bharath Naravetla, MD
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Trinity Health Saint Mary's
    - Contact:
      
      Muhammad Farooq, MD
  - Grand Rapids, Michigan, United States, 49503
    - Withdrawn
    - Trinity Health Saint Mary's
  - Mount Clemens, Michigan, United States, 48043
    - Recruiting
    - McLaren Macomb
    - Contact:
      
      Bharath Naravetla, MD
  - Traverse City, Michigan, United States, 49684
    - Recruiting
    - Munson Medical Center
    - Contact:
      
      David Rosenbaum, MD
  - Wyoming, Michigan, United States, 49519
    - Withdrawn
    - Metro Health Hospital
- Minnesota
  - Minneapolis, Minnesota, United States, 55407
    - Recruiting
    - Abbott Northwestern Hospital
    - Contact:
      
      Ganesh Asaithambi, MD
  - Minneapolis, Minnesota, United States, 55455
    - Recruiting
    - M Health Fairview University of Minnesota Medical Center
    - Contact:
      
      Oladi Bentho, MD
  - Saint Cloud, Minnesota, United States, 56303
    - Recruiting
    - St. Cloud Hospital
    - Contact:
      
      Muhammad Fareed Suri, MD
  - Saint Louis Park, Minnesota, United States, 55426
    - Recruiting
    - HealthPartners Methodist Hospital
    - Contact:
      
      Darwin Ramirez Abreu, MD
  - Saint Paul, Minnesota, United States, 55101
    - Recruiting
    - Regions Hospital
    - Contact:
      
      Darwin Ramirez-Abreu, MD
  - Saint Paul, Minnesota, United States, 55102
    - Withdrawn
    - United Hospital, St. Paul
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Recruiting
    - University of Mississippi Medical Center
    - Contact:
      
      Allison Strickland, MD
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Recruiting
    - Barnes Jewish Hospital
    - Contact:
      
      Yan Wang, MD
  - Springfield, Missouri, United States, 65807
    - Recruiting
    - Cox Medical Center South
    - Contact:
      
      Benjamin Lisle, MD
- Nebraska
  - Omaha, Nebraska, United States, 68105
    - Recruiting
    - University of Nebraska Medical Center
    - Contact:
      
      Marco Gonzalez Castellon, MD
- New Jersey
  - Summit, New Jersey, United States, 07901
    - Recruiting
    - Overlook Medical Center
    - Contact:
      
      John Hanna, MD
  - Trenton, New Jersey, United States, 08638
    - Withdrawn
    - Capital Health Regional Medical Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - Recruiting
    - University of New Mexico Hospital
    - Contact:
      
      Tarun Girotra, MD
- New York
  - Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Medical Center
    - Contact:
      
      Kathryn Kirchoff-Torres, MD
  - Brooklyn, New York, United States, 11219
    - Recruiting
    - Maimonides Medical Center
    - Contact:
      
      Quingliang Wang, MD
  - Brooklyn, New York, United States, 11203
    - Recruiting
    - Kings County Hospital Center
    - Contact:
      
      Susan Law, MD
  - Brooklyn, New York, United States, 11220
    - Recruiting
    - NYU Langone Hospital - Brooklyn
    - Contact:
      
      Jennifer Frontera
  - Brooklyn, New York, United States, 11215
    - Active, not recruiting
    - NewYork-Presbyterian Brooklyn Methodist Hospital
  - Buffalo, New York, United States, 14202
    - Active, not recruiting
    - Buffalo General Medical Center
  - Manhasset, New York, United States, 11030
    - Recruiting
    - North Shore University Hospital
    - Contact:
      
      Rohan Arora, MD
  - New York, New York, United States, 10019
    - Recruiting
    - Mount Sinai West
    - Contact:
      
      Neha Dangayach, MD
  - New York, New York, United States, 10029
    - Recruiting
    - The Mount Sinai Hospital
    - Contact:
      
      Neha Dangayach, MD
  - New York, New York, United States, 10065
    - Recruiting
    - NYP Weill Cornell Medical Center
    - Contact:
      
      Hooman Kamel, MD
  - New York, New York, United States, 10032
    - Recruiting
    - NYP Columbia University Medical Center
    - Contact:
      
      Imama Naqvi, MD
  - Poughkeepsie, New York, United States, 12601
    - Recruiting
    - Vassar Brothers Medical Center
    - Contact:
      
      Paul Wright, MD
  - Rochester, New York, United States, 14642
    - Recruiting
    - Strong Memorial Hospital
    - Contact:
      
      Curtis Benesch, MD
  - Staten Island, New York, United States, 10305
    - Withdrawn
    - Staten Island University Hospital - North Campus
  - Stony Brook, New York, United States, 11794
    - Recruiting
    - Stony Brook University Hospital
    - Contact:
      
      Jason Mathew, MD
  - Syracuse, New York, United States, 13210
    - Recruiting
    - SUNY Upstate Medical University
    - Contact:
      
      Julius-Gene Latorre, MD
  - Valhalla, New York, United States, 10595
    - Recruiting
    - Westchester Medical Center
    - Contact:
      
      Stephan Mayer, MD
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Recruiting
    - University of North Carolina Medical Center
    - Contact:
      
      David Huang, MD
  - Charlotte, North Carolina, United States, 28204
    - Withdrawn
    - Carolinas Medical Center
  - Greensboro, North Carolina, United States, 27401
    - Active, not recruiting
    - Moses H. Cone Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Wake Forest Baptist Medical Center
    - Contact:
      
      Stacey Wolfe, MD
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Forsyth Medical Center
    - Contact:
      
      Lauren Peruski, MD
- Ohio
  - Akron, Ohio, United States, 44307
    - Recruiting
    - Cleveland Clinic Akron General
    - Contact:
      
      Ahmed Itrat, MD
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - University of Cincinnati Medical Center
    - Contact:
      
      Rob Stanton, MD
  - Cincinnati, Ohio, United States, 45220
    - Recruiting
    - Good Samaritan Hospital
    - Contact:
      
      Christopher Zammit, MD
  - Cleveland, Ohio, United States, 44109
    - Recruiting
    - MetroHealth Medical Center
    - Contact:
      
      Agnieszka Ardelt, MD
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic
    - Contact:
      
      Blake Buletko
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - UH Cleveland Medical Center
    - Contact:
      
      Abhishek Ray, MD
  - Columbus, Ohio, United States, 43214
    - Recruiting
    - Riverside Methodist Hospital
    - Contact:
      
      Vivek Rai, MD
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - OSU Wexner Medical Center
    - Contact:
      
      Yousef Hannawi, MD
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - Recruiting
    - OU Medical Center
    - Contact:
      
      Evgeny Sidorov
  - Tulsa, Oklahoma, United States, 74104
    - Recruiting
    - St. John Medical Center
    - Contact:
      
      Rahul Rahangdale, MD
  - Tulsa, Oklahoma, United States, 74104
    - Recruiting
    - Ascension St. John Medical Center
    - Contact:
      
      Rahul Rahangdale, MD
- Oregon
  - Portland, Oregon, United States, 92739
    - Recruiting
    - Oregon Health & Science University Hospital
    - Contact:
      
      Wayne Clark
  - Portland, Oregon, United States, 97213
    - Recruiting
    - Providence St. Vincent Medical Center
    - Contact:
      
      John Zurasky
  - Springfield, Oregon, United States, 97477
    - Recruiting
    - PeaceHealth Sacred Heart Medical Center - RiverBend
    - Contact:
      
      Elaine Skalabrin, MD
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Recruiting
    - Jefferson Abington Hospital
    - Contact:
      
      Larami MacKenzie, MD
  - Allentown, Pennsylvania, United States, 18103
    - Withdrawn
    - Lehigh Valley Hospital - Cedar Crest
  - Danville, Pennsylvania, United States, 17822
    - Recruiting
    - Geisinger Medical Center
    - Contact:
      
      Clemens Schirmer, MD
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Penn State Hershey Medical Center
    - Contact:
      
      Nandakumar Nagaraja, MD
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University Hospital
    - Contact:
      
      Diana Tzeng, MD
  - Philadelphia, Pennsylvania, United States, 19140
    - Recruiting
    - Temple University Hospital
    - Contact:
      
      Paul Katz, MD
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Hospital of the University of Pennsylvania
    - Contact:
      
      Jens Witsch, MD
  - Pittsburgh, Pennsylvania, United States, 15213
    - Recruiting
    - UPMC Presbyterian Hospital
    - Contact:
      
      Marcelo Rocha
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Recruiting
    - Rhode Island Hospital
    - Contact:
      
      Torrey Birch, MD
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina University Hospital
    - Contact:
      
      Christine Holmstedt, MD
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Greenville Hospital System
    - Contact:
      
      Sanjeev Sivakumar, MD
- South Dakota
  - Sioux Falls, South Dakota, United States, 57108
    - Recruiting
    - Avera Research Institute
    - Contact:
      
      Jonathon Cooke, MD
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Recruiting
    - Erlanger Health System
    - Contact:
      
      Mounzer Kassab, MD
  - Knoxville, Tennessee, United States, 37916
    - Recruiting
    - Fort Sanders Regional Medical Center
    - Contact:
      
      S. Arthur Moore, MD
  - Memphis, Tennessee, United States, 38104
    - Recruiting
    - Methodist University Hospital
    - Contact:
      
      Balaji Krishnaiah, MD
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Hospital
    - Contact:
      
      Deborah Kerrigan, MD
- Texas
  - Austin, Texas, United States, 78705
    - Withdrawn
    - St. David's Medical Center
  - Dallas, Texas, United States, 75390
    - Withdrawn
    - UT Southwestern Medical Center
  - Houston, Texas, United States, 77030
    - Recruiting
    - Houston Methodist Hospital
    - Contact:
      
      Britz Britz, MD
  - Houston, Texas, United States, 77030
    - Recruiting
    - Memorial Hermann Texas Medical Center
    - Contact:
      
      Andrew Barreto, MD
  - Houston, Texas, United States, 77030
    - Suspended
    - Baylor College of Medicine Medical Center
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - University of Texas Health Science Center San Antonio
    - Contact:
      
      Reza Behrouz, MD
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - University of Utah Healthcare
    - Contact:
      
      Nabeel Chauhan, MD
- Vermont
  - Burlington, Vermont, United States, 05401
    - Recruiting
    - The University of Vermont Medical Center
    - Contact:
      
      Chris Commichau
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - UVA Medical Center
    - Contact:
      
      Brad Worral, MD
  - Falls Church, Virginia, United States, 22042
    - Recruiting
    - Inova Fairfax Hospital
    - Contact:
      
      Saqib Chaudhry, MD
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - VCU Medical Center
    - Contact:
      
      Shraddha Mainali, MD
- Washington
  - Seattle, Washington, United States, 98104
    - Recruiting
    - Harborview Medical Center
    - Contact:
      
      David Tirschwell, MD
  - Seattle, Washington, United States, 98101
    - Withdrawn
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98122
    - Recruiting
    - Swedish Medical Center - Cherry Hill Campus
    - Contact:
      
      James Bartscher, MD
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - WVU Healthcare Ruby Memorial Hospital
    - Contact:
      
      Amelia Adcock, MD
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Froedtert Hospital
    - Contact:
      
      Hatim Attar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or death Time Frame: Up to 3 years	Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS) score Time Frame: Change from baseline to 12 months; change over duration of follow-up	Measure of neurologic disability (0=no disability to 6=dead)	Change from baseline to 12 months; change over duration of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator: Kevin N Sheth, MD, Yale School of Medicine
Principal Investigator: Hooman Kamel, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2020

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 8, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

2000026409
1U01NS106513-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Apixaban

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