RECRUITINGPhase 3INTERVENTIONAL
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form by patient or legally authorized representative
- For females of reproductive potential: use of highly effective contraception
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Apixaban
Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.
DRUG
Aspirin
Aspirin is an oral antiplatelet drug.
Locations (20)
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