Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Yale University
Study ID: NCT03907046
Phase: PHASE3
Status: Recruiting

Apply to this trial

Conditions

Atrial Fibrillation
Intracerebral Hemorrhage

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Apixaban — DRUG
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
Aspirin — DRUG
Aspirin is an oral antiplatelet drug.

Study Details

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.

Key Dates

Start date: Jan 28, 2020
Status verified: May 2026
Primary completion: Apr 30, 2027
Completion: Apr 30, 2027

Study Design

Enrollment: 700 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Arms

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.

Primary Outcome Measure

Stroke or death [ Time Frame: Up to 3 years ]

Central Contacts

Kevin N Sheth, MD
443-615-4729
[email protected]
Hooman Kamel, MD
646-962-8284
[email protected]

Locations (187)

Facility	City	State	ZIP	Site coordinators
University of Alabama Hospital	Birmingham	Alabama	35294	Angela Shapshak, MD
University of South Alabama University Hospital	Mobile	Alabama	36604	Taha Nisar, MD
Chandler Regional Medical Center	Chandler	Arizona	85224	-
St. Joseph's Hospital and Medical Center	Phoenix	Arizona	85013	-
Banner University Medical Center	Tucson	Arizona	85719	Firas Kaddouh, MD
UAMS Medical Center	Little Rock	Arkansas	77205	-
Mercy San Juan Medical Center	Carmichael	California	95608	Lucian Maidan
Eden Medical Center, Castro Valley	Castro Valley	California	94546	-
Arrowhead Regional Medical Center	Colton	California	92324	Dan Miulli, MD
Rancho Los Amigos National Rehabilitation Center	Downey	California	90242	-
Kaiser Permanente Fontana Medical Center	Fontana	California	92335	Vaninder Chhabra
Community Regional Medical Center of Fresno	Fresno	California	93720	Mellekate Vishwas, MD
St. Jude Medical Center	Fullerton	California	92835	Ashish Nanda, MD
Long Beach Memorial Medical Center	Long Beach	California	90806	-
Los Alamitos Medical Center	Los Alamitos	California	90720	Nirav Patel, MD
Cedars-Sinai Medical Center	Los Angeles	California	90048	Konrad Schlick, MD
Kaiser Permanente Los Angeles Medical Center	Los Angeles	California	90027	Harsimran Brara, MD
Ronald Reagan UCLA Medical Center	Los Angeles	California	90095	Latisha Sharma, MD
Doctors Medical Center Modesto, Modesto, CA	Modesto	California	95350	James Jaffe, MD
Hoag Hospital Newport Beach	Newport Beach	California	92663	-
UC Irvine Medical Center	Orange	California	92868	Wengui Yu, MD
Desert Regional Medical Center	Palm Springs	California	92262	Kevin Attenhofer, MD
Huntington Memorial Hospital	Pasadena	California	91105	-
Kaiser Permanente Redwood City Medical Center, Redwood City, CA	Redwood City	California	94063	Sheila Chan, MD
Kaiser Permanente Sacramento Medical Center	Sacramento	California	95825	Yekaterina Axelrod, MD
UC Davis Medical Center	Sacramento	California	95817	Kwan Ng, MD
San Francisco General Hospital	San Francisco	California	94110	Claude Hemphill, MD
Santa Barbara Cottage Hospital	Santa Barbara	California	93105	Brian Walcott, MD
Stanford University Medical Center	Stanford	California	94304	Chitra Venkat, MD
PIH Health Hospital - Whittier	Whittier	California	90602	Gautam Ganguly, MD
University of Colorado Hospital	Aurora	Colorado	80045	Sharon Poisson, MD
St. Mary's Medical Center	Grand Junction	Colorado	81501	-
Danbury Hospital	Danbury	Connecticut	06810	-
Hartford Hospital	Hartford	Connecticut	06102	Mark Alberts, MD
Yale New Haven Hospital	New Haven	Connecticut	06511	Guido Falcone, MD
New Hanover Regional Medical Center	Wilmington	Delaware	28403	James McKinney, MD
George Washington University Hospital	Washington D.C.	District of Columbia	20037	Fernando Mayor Basto, MD
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia	20007	Douglas Mayson, MD
MedStar Washington Hospital Center	Washington D.C.	District of Columbia	20010	-
Morton Plant Hospital	Clearwater	Florida	33756	Ajay Arora, MD
Broward Health Medical Center	Fort Lauderdale	Florida	33316	Mehdi Mehdi, MD
Mayo Clinic	Jacksonville	Florida	32224	-
UF Health Jacksonville	Jacksonville	Florida	32209	Kimberly McPhearson, MD
Jackson Memorial Hospital	Miami	Florida	33136	Sebastian Koch
Ascension Sacred Heart Pensacola	Pensacola	Florida	32504	Terry Neill, MD
Cleveland Clinic Tradition Hospital	Port Saint Lucie	Florida	34987	Marc Babi, MD
St. Joseph's Hospital	Tampa	Florida	33607	Abilash Haridas, MD
Tampa General Hospital	Tampa	Florida	33606	Swetha Renati, MD
Emory University Hospital	Atlanta	Georgia	30322	Fadi Nahab, MD
Grady Memorial Hospital	Atlanta	Georgia	30303	Daniel Schachter, MD
Augusta University Medical Center	Augusta	Georgia	30912	Fenwick Nichols, MD
WellStar Kennestone Hospital	Marietta	Georgia	30060	Christopher Horn, MD
The Queen's Medical Center	Honolulu	Hawaii	96813	Kazuma Nakagawa, MD
Saint Alphonsus Regional Medical Center - Boise	Boise	Idaho	83706	Lukas Clark, MD
NCH Hospital, Arlington Heights	Arlington Heights	Illinois	60005	Mohammad Anadani, MD
Rush University Medical Center	Chicago	Illinois	60612	Alejandro Vargas, MD
University of Chicago Medical Center	Chicago	Illinois	60637	Rachel Mehendale, MD
University of Illinois Hospital	Chicago	Illinois	60612	Ali Alaraj, MD
Evanston Hospital	Evanston	Illinois	60201	Mohammad Anadani, MD
Loyola University Medical Center	Maywood	Illinois	60153	Sarkis Morales-Vidal, MD
OSF St. Francis Medical Center	Peoria	Illinois	61637	Arun Talkad
Javon Bea Hospital - Riverside	Rockford	Illinois	61114	-
St. John's Hospital	Springfield	Illinois	62769	-
Central DuPage Hospital	Winfield	Illinois	60190	Dhruvil Pandya, MD
IU Health Methodist Hospital	Indianapolis	Indiana	46202	Lisa Nobel, MD
University of Iowa Medical Center	Iowa City	Iowa	52242	Amir Shaban, MD
University of Kansas Hospital	Kansas City	Kansas	66160	Kyle Carpenter, MD
Baptist Health Lexington	Lexington	Kentucky	40503	Murali Kolikonda, MD
University of Kentucky Hospital	Lexington	Kentucky	40536	Suhas Gangadhara, MD
University of Louisville Hospital	Louisville	Kentucky	40202	Isaac Abecassis, MD
Ochsner Medical Center - Main Campus	New Orleans	Louisiana	70121	Richard Zweifler
Eastern Maine Medical Center	Bangor	Maine	04401	-
Maine Medical Center	Portland	Maine	04102	Teresa May, MD
Beth Israel Deaconess Medical Center	Boston	Massachusetts	02215	Magdy Selim, MD
Boston Medical Center	Boston	Massachusetts	02118	Steven Feske, MD
Massachusetts General Hospital	Boston	Massachusetts	02114	Mariel Kozberg, MD
Tufts Medical Center	Boston	Massachusetts	02111	Emiliya Melkumova, MD
Lahey Hospital & Medical Center	Burlington	Massachusetts	01805	Colin James Culbertson, MD
Baystate Medical Center	Springfield	Massachusetts	01199	Gottfried Schlaug, MD
UMass Memorial Medical Center	Worcester	Massachusetts	01655	Majaz Moonis, MD
University of Michigan University Hospital	Ann Arbor	Michigan	48109	-
Henry Ford Hospital	Detroit	Michigan	48202	-
McLaren Flint	Flint	Michigan	48532	-
Trinity Health Saint Mary's	Grand Rapids	Michigan	49503	-
Trinity Health Saint Mary's	Grand Rapids	Michigan	49503	Muhammad Farooq, MD
McLaren Macomb	Mount Clemens	Michigan	48043	-
Munson Medical Center	Traverse City	Michigan	49684	Ramiro Castro-Apolo, MD
Metro Health Hospital	Wyoming	Michigan	49519	-
Abbott Northwestern Hospital	Minneapolis	Minnesota	55407	Ganesh Asaithambi, MD
M Health Fairview University of Minnesota Medical Center	Minneapolis	Minnesota	55455	Oladi Bentho, MD
St. Cloud Hospital	Saint Cloud	Minnesota	56303	Muhammad Fareed Suri, MD
HealthPartners Methodist Hospital	Saint Louis Park	Minnesota	55426	-
Regions Hospital	Saint Paul	Minnesota	55101	-
United Hospital, St. Paul	Saint Paul	Minnesota	55102	-
University of Mississippi Medical Center	Jackson	Mississippi	39216	-
University of Missouri Health Care	Columbia	Missouri	65212	Farhan Siddiq, MD
Cox Medical Center South	Springfield	Missouri	65807	Benjamin Lisle, MD
Mercy Hospital Springfield	Springfield	Missouri	65804	Brenton Coger, MD
Barnes Jewish Hospital	St Louis	Missouri	63110	Yan Wang, MD
Mercy Hospital South	St Louis	Missouri	63128	Venkat Chintapally-Rao, MD
Mercy Hospital St. Louis	St Louis	Missouri	63141	Nida Jamal, MD
University of Nebraska Medical Center	Omaha	Nebraska	68105	Pierre Fayad, MD
JFK Medical Center	Edison	New Jersey	08820	Navid Tabibzadeh, MD
Hackensack University Medical Center	Hackensack	New Jersey	07601	Kaitlin Reilly-Kit, MD
Cooperman Barnabas Medical Center	Livingston	New Jersey	07052	Steven Shapiro, MD
Jersey Shore University Medical Center	Neptune City	New Jersey	07753	Ephrem Teklemariam, MD
Overlook Medical Center	Summit	New Jersey	07901	Marianna Atiya, MD
Capital Health Regional Medical Center	Trenton	New Jersey	08638	-
University of New Mexico Hospital	Albuquerque	New Mexico	87106	-
Albany Medical Center	Albany	New York	12208	Dylan Jones, MD
Kings County Hospital Center	Brooklyn	New York	11203	Susan Law, MD
Maimonides Medical Center	Brooklyn	New York	11219	-
NewYork-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York	11215	-
NYU Langone Hospital - Brooklyn	Brooklyn	New York	11220	Jennifer Frontera
Buffalo General Medical Center	Buffalo	New York	14202	-
NYC Health + Hospitals/Elmhurst	Elmhurst	New York	11373	Hazem Shoirah, MD
North Shore University Hospital	Manhasset	New York	11030	Rohan Arora, MD
Mount Sinai West	New York	New York	10019	Neha Dangayach, MD
NYP Columbia University Medical Center	New York	New York	10032	Imama Naqvi, MD
NYP Weill Cornell Medical Center	New York	New York	10065	Hooman Kamel, MD
The Mount Sinai Hospital	New York	New York	10029	Neha Dangayach, MD
Vassar Brothers Medical Center	Poughkeepsie	New York	12601	-
Strong Memorial Hospital	Rochester	New York	14642	Curtis Benesch, MD
Staten Island University Hospital - North Campus	Staten Island	New York	10305	-
Stony Brook University Hospital	Stony Brook	New York	11794	Jason Mathew, MD
SUNY Upstate Medical University	Syracuse	New York	13210	Julius-Gene Latorre, MD
Montefiore Medical Center	The Bronx	New York	10467	Kathryn Kirchoff-Torres, MD
Westchester Medical Center	Valhalla	New York	10595	Stephan Mayer, MD
Burke Rehabilitation Center	White Plains	New York	10605	Kathryn Kirchoff-Torres, MD
University of North Carolina Medical Center	Chapel Hill	North Carolina	27514	Julia Carlson, MD
Carolinas Medical Center	Charlotte	North Carolina	28204	-
Presbyterian Medical Center	Charlotte	North Carolina	28204	Melanie Greenway, MD
Duke University Hospital	Durham	North Carolina	27710	Dylan Ryan, MD
Moses H. Cone Memorial Hospital	Greensboro	North Carolina	27401	Pramod Sethi, MD
ECU Health Medical Center	Greenville	North Carolina	27834	Shailesh Male, MD
New Hanover Regional Medical Center	Wilmington	North Carolina	28403	Amanda Pardon, MD
Forsyth Medical Center	Winston-Salem	North Carolina	27103	Mitchell Hargis, MD
Wake Forest Baptist Medical Center	Winston-Salem	North Carolina	27157	Stacey Wolfe, MD
Cleveland Clinic Akron General	Akron	Ohio	44307	Ahmed Itrat, MD
Good Samaritan Hospital	Cincinnati	Ohio	45220	Chengyuan Feng, MD
University of Cincinnati Medical Center	Cincinnati	Ohio	45219	Rob Stanton, MD
Cleveland Clinic	Cleveland	Ohio	44195	Blake Buletko
MetroHealth Medical Center	Cleveland	Ohio	44109	Agnieszka Ardelt, MD
UH Cleveland Medical Center	Cleveland	Ohio	44106	Abhishek Ray, MD
OSU Wexner Medical Center	Columbus	Ohio	43210	Yousef Hannawi, MD
Riverside Methodist Hospital	Columbus	Ohio	43214	Vivek Rai, MD
Mercy Hospital Oklahoma City	Oklahoma City	Oklahoma	73120	Jeffrey Craig, MD
OU Medical Center	Oklahoma City	Oklahoma	73104	Evgeny Sidorov
Ascension St. John Medical Center	Tulsa	Oklahoma	74104	Rahul Rahangdale, MD
St. John Medical Center	Tulsa	Oklahoma	74104	Rahul Rahangdale, MD
Oregon Health & Science University Hospital	Portland	Oregon	92739	Wayne Clark
Providence St. Vincent Medical Center	Portland	Oregon	97213	John Zurasky
PeaceHealth Sacred Heart Medical Center - RiverBend	Springfield	Oregon	97477	Mariam Tsikvadze, MD
Jefferson Abington Hospital	Abington	Pennsylvania	19001	Larami MacKenzie, MD
Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania	18103	-
Geisinger Medical Center	Danville	Pennsylvania	17822	-
Penn State Hershey Medical Center	Hershey	Pennsylvania	17033	Nandakumar Nagaraja, MD
Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	19104	Aaron Rothstein, MD
Temple University Hospital	Philadelphia	Pennsylvania	19140	Paul Katz, MD
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	19107	-
UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania	15213	Marcelo Rocha
Rhode Island Hospital	Providence	Rhode Island	02903	-
Medical University of South Carolina University Hospital	Charleston	South Carolina	29425	Christine Holmstedt, MD
Greenville Hospital System	Greenville	South Carolina	29605	Sanjeev Sivakumar, MD
Avera Research Institute	Sioux Falls	South Dakota	57108	Jonathon Cooke, MD
Erlanger Health System	Chattanooga	Tennessee	37403	-
Fort Sanders Regional Medical Center	Knoxville	Tennessee	37916	S. Arthur Moore, MD
Methodist University Hospital	Memphis	Tennessee	38104	Balaji Krishnaiah, MD
Semmes Murphey Main Campus	Memphis	Tennessee	38120	Neha Kumar, MD
Vanderbilt University Hospital	Nashville	Tennessee	37232	Deborah Kerrigan, MD
St. David's Medical Center	Austin	Texas	78705	-
UT Southwestern Medical Center	Dallas	Texas	75390	-
Baylor College of Medicine Medical Center	Houston	Texas	77030	-
Houston Methodist Hospital	Houston	Texas	77030	Britz Britz, MD
Memorial Hermann Texas Medical Center	Houston	Texas	77030	Andrew Barreto, MD
University of Texas Health Science Center San Antonio	San Antonio	Texas	78229	Reza Behrouz, MD
University of Utah Healthcare	Salt Lake City	Utah	84112	Nabeel Chauhan, MD
The University of Vermont Medical Center	Burlington	Vermont	05401	Chris Commichau
UVA Medical Center	Charlottesville	Virginia	22908	Brad Worral, MD
Inova Fairfax Hospital	Falls Church	Virginia	22042	Saqib Chaudhry, MD
Bon Secours St. Mary's Hospital	Richmond	Virginia	23226	Amandeep Sangha, MD
VCU Medical Center	Richmond	Virginia	23298	-
Harborview Medical Center	Seattle	Washington	98104	David Tirschwell, MD
Swedish Medical Center - Cherry Hill Campus	Seattle	Washington	98122	-
Virginia Mason Medical Center	Seattle	Washington	98101	-
J.W. Ruby Memorial Hospital	Morgantown	West Virginia	26506	Amelia Adcock, MD
Froedtert Hospital	Milwaukee	Wisconsin	53226	-

Find similar trials in Birmingham, AL

By condition

Atrial fibrillation

By specialty

Cardiology Heart disease

By research site

University of Alabama Hospital· Birmingham, AL University of South Alabama University Hospital· Mobile, AL Chandler Regional Medical Center· Chandler, AZ St. Joseph's Hospital and Medical Center· Phoenix, AZ Banner University Medical Center· Tucson, AZ UAMS Medical Center· Little Rock, AR

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