Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Atrial Fibrillation Clinical Trial

— ASPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03907046
• Other study ID #: 2000026409
• Secondary ID: 1U01NS106513-01A
• Status: Recruiting
• Phase: Phase 3
• Start date: January 28, 2020
• Est. completion date: April 2027

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Kevin N Sheth, MD
• Phone: 443-615-4729
• Email: kevin.sheth[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• Apixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
• Aspirin
Aspirin is an oral antiplatelet drug.

Locations

Country	Name	City	State
United States	Jefferson Abington Hospital	Abington	Pennsylvania
United States	Cleveland Clinic Akron General	Akron	Ohio
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	Lehigh Valley Hospital - Cedar Crest	Allentown	Pennsylvania
United States	University of Michigan University Hospital	Ann Arbor	Michigan
United States	NCH Hospital, Arlington Heights	Arlington Heights	Illinois
United States	Emory University Hospital	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Augusta University Medical Center	Augusta	Georgia
United States	St. David's Medical Center	Austin	Texas
United States	Eastern Maine Medical Center	Bangor	Maine
United States	University of Alabama Hospital	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Kings County Hospital Center	Brooklyn	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	NewYork-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	NYU Langone Hospital - Brooklyn	Brooklyn	New York
United States	Buffalo General Medical Center	Buffalo	New York
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	The University of Vermont Medical Center	Burlington	Vermont
United States	Mercy San Juan Medical Center	Carmichael	California
United States	Eden Medical Center, Castro Valley	Castro Valley	California
United States	Chandler Regional Medical Center	Chandler	Arizona
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina University Hospital	Charleston	South Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	UVA Medical Center	Charlottesville	Virginia
United States	Erlanger Health System	Chattanooga	Tennessee
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Illinois Hospital	Chicago	Illinois
United States	Good Samaritan Hospital	Cincinnati	Ohio
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Morton Plant Hospital	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	UH Cleveland Medical Center	Cleveland	Ohio
United States	Arrowhead Regional Medical Center	Colton	California
United States	OSU Wexner Medical Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Danbury Hospital	Danbury	Connecticut
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Henry Ford Hospital	Detroit	Michigan
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	McLaren Flint	Flint	Michigan
United States	Kaiser Permanente Fontana Medical Center	Fontana	California
United States	St. Mary's Medical Center	Grand Junction	Colorado
United States	Trinity Health Saint Mary's	Grand Rapids	Michigan
United States	Trinity Health Saint Mary's	Grand Rapids	Michigan
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	Greenville Hospital System	Greenville	South Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Baylor College of Medicine Medical Center	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Memorial Hermann Texas Medical Center	Houston	Texas
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	UAMS Medical Center	Little Rock	Arkansas
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Los Alamitos Medical Center	Los Alamitos	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	WellStar Kennestone Hospital	Marietta	Georgia
United States	Loyola University Medical Center	Maywood	Illinois
United States	Methodist University Hospital	Memphis	Tennessee
United States	Jackson Memorial Hospital	Miami	Florida
United States	Froedtert Hospital	Milwaukee	Wisconsin
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	M Health Fairview University of Minnesota Medical Center	Minneapolis	Minnesota
United States	University of South Alabama University Hospital	Mobile	Alabama
United States	Doctors Medical Center Modesto, Modesto, CA	Modesto	California
United States	WVU Healthcare Ruby Memorial Hospital	Morgantown	West Virginia
United States	McLaren Macomb	Mount Clemens	Michigan
United States	Vanderbilt University Hospital	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Ochsner Medical Center - Main Campus	New Orleans	Louisiana
United States	Mount Sinai West	New York	New York
United States	NYP Columbia University Medical Center	New York	New York
United States	NYP Weill Cornell Medical Center	New York	New York
United States	The Mount Sinai Hospital	New York	New York
United States	Hoag Hospital Newport Beach	Newport Beach	California
United States	OU Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	UC Irvine Medical Center	Orange	California
United States	Desert Regional Medical Center	Palm Springs	California
United States	Huntington Memorial Hospital	Pasadena	California
United States	Ascension Sacred Heart Pensacola	Pensacola	Florida
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania
United States	Cleveland Clinic Tradition Hospital	Port Saint Lucie	Florida
United States	Oregon Health & Science University Hospital	Portland	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Kaiser Permanente Redwood City Medical Center, Redwood City, CA	Redwood City	California
United States	VCU Medical Center	Richmond	Virginia
United States	Strong Memorial Hospital	Rochester	New York
United States	Javon Bea Hospital - Riverside	Rockford	Illinois
United States	Kaiser Permanente Sacramento Medical Center	Sacramento	California
United States	UC Davis Medical Center	Sacramento	California
United States	St. Cloud Hospital	Saint Cloud	Minnesota
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	HealthPartners Methodist Hospital	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital, St. Paul	Saint Paul	Minnesota
United States	University of Utah Healthcare	Salt Lake City	Utah
United States	University of Texas Health Science Center San Antonio	San Antonio	Texas
United States	San Francisco General Hospital	San Francisco	California
United States	Harborview Medical Center	Seattle	Washington
United States	Swedish Medical Center - Cherry Hill Campus	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Cox Medical Center South	Springfield	Missouri
United States	PeaceHealth Sacred Heart Medical Center - RiverBend	Springfield	Oregon
United States	St. John's Hospital	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Staten Island University Hospital - North Campus	Staten Island	New York
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Overlook Medical Center	Summit	New Jersey
United States	SUNY Upstate Medical University	Syracuse	New York
United States	St. Joseph's Hospital	Tampa	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	Munson Medical Center	Traverse City	Michigan
United States	Capital Health Regional Medical Center	Trenton	New Jersey
United States	Banner University Medical Center	Tucson	Arizona
United States	Ascension St. John Medical Center	Tulsa	Oklahoma
United States	St. John Medical Center	Tulsa	Oklahoma
United States	Westchester Medical Center	Valhalla	New York
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	PIH Health Hospital - Whittier	Whittier	California
United States	New Hanover Regional Medical Center	Wilmington	Delaware
United States	Central DuPage Hospital	Winfield	Illinois
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke or death	Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause	Up to 3 years
Secondary	Modified Rankin Scale (mRS) score	Measure of neurologic disability (0=no disability to 6=dead)	Change from baseline to 12 months; change over duration of follow-up