Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Recruiting · NCT03907046 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 44 US states.
- University of Alabama Hospital - Birmingham, Alabama, United States
- University of South Alabama University Hospital - Mobile, Alabama, United States
- Chandler Regional Medical Center - Chandler, Arizona, United States
- St. Joseph's Hospital and Medical Center - Phoenix, Arizona, United States
- Banner University Medical Center - Tucson, Arizona, United States
- UAMS Medical Center - Little Rock, Arkansas, United States
- Mercy San Juan Medical Center - Carmichael, California, United States
- Eden Medical Center, Castro Valley - Castro Valley, California, United States
- Arrowhead Regional Medical Center - Colton, California, United States
- Rancho Los Amigos National Rehabilitation Center - Downey, California, United States
- Kaiser Permanente Fontana Medical Center - Fontana, California, United States
- Community Regional Medical Center of Fresno - Fresno, California, United States
- St. Jude Medical Center - Fullerton, California, United States
- Long Beach Memorial Medical Center - Long Beach, California, United States
- Los Alamitos Medical Center - Los Alamitos, California, United States
- Kaiser Permanente Los Angeles Medical Center - Los Angeles, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center - Los Angeles, California, United States
- Doctors Medical Center Modesto, Modesto, CA - Modesto, California, United States
- Hoag Hospital Newport Beach - Newport Beach, California, 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
- Kaiser Permanente Redwood City Medical Center, Redwood City, CA - Redwood City, California, United States
- UC Davis Medical Center - Sacramento, California, United States
- Kaiser Permanente Sacramento Medical Center - Sacramento, California, United States
- San Francisco General Hospital - San Francisco, California, United States
- Santa Barbara Cottage Hospital - Santa Barbara, California, United States
- Stanford University Medical Center - Stanford, California, United States
- PIH Health Hospital - Whittier - Whittier, California, United States
- University of Colorado Hospital - Aurora, Colorado, United States
- St. Mary's Medical Center - Grand Junction, Colorado, United States
- Danbury Hospital - Danbury, Connecticut, United States
- Hartford Hospital - Hartford, Connecticut, United States
- Yale New Haven Hospital - New Haven, Connecticut, United States
- New Hanover Regional Medical Center - Wilmington, Delaware, United States
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center - Washington D.C., District of Columbia, United States
- George Washington University Hospital - Washington D.C., District of Columbia, United States
- Morton Plant Hospital - Clearwater, Florida, United States
- Broward Health Medical Center - Fort Lauderdale, Florida, United States
- UF Health Jacksonville - Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- Jackson Memorial Hospital - Miami, Florida, United States
- Ascension Sacred Heart Pensacola - Pensacola, Florida, United States
- Cleveland Clinic Tradition Hospital - Port Saint Lucie, Florida, United States
- Tampa General Hospital - Tampa, Florida, United States
- St. Joseph's Hospital - Tampa, Florida, United States
- Grady Memorial Hospital - Atlanta, Georgia, United States
- Emory University Hospital - Atlanta, Georgia, United States
- Augusta University Medical Center - Augusta, Georgia, United States
- WellStar Kennestone Hospital - Marietta, Georgia, United States
- The Queen's Medical Center - Honolulu, Hawaii, United States
- Saint Alphonsus Regional Medical Center - Boise - Boise, Idaho, United States
- NCH Hospital, Arlington Heights - Arlington Heights, Illinois, United States
- Rush University Medical Center - Chicago, Illinois, United States
- University of Illinois Hospital - Chicago, Illinois, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Evanston Hospital - Evanston, Illinois, United States
- Loyola University Medical Center - Maywood, Illinois, United States
Showing 60 of 187 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →