Intracerebral Hemorrhage study: Apixaban vs Aspirin
Official title Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
ClinicalTrials.gov ID: NCT03907046
What this study is testing
What is Apixaban?
This is an investigational oral medicine being studied to see if it helps prevent strokes or death in people with atrial fibrillation who recently had a brain bleed. It is designed to block a specific protein in the blood called Factor Xa to help prevent blood clots from forming.
Also referred to as Eliquis.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if apixaban is better than aspirin at preventing new strokes or death. It also checks if apixaban helps people recover better physically.
- Who it's for
- People who have recently had a bleed in the brain and also have a heart rhythm problem called atrial fibrillation.
- What's involved
- Participants will take either apixaban or aspirin. They will have regular check-ups and tests to monitor their health and recovery.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age at least 18 years
- Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
- Can be assigned by chance 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
You likely can't join if
- 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...
- Previous or planned left atrial appendage closure
- Clinically significant bleeding diathesis
See the full eligibility criteria
- Age at least 18 years
- Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI
- Can be assigned by chance 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Tucson, Arizona, United States
- Carmichael, California, United States
- Colton, California, United States
- Fontana, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Orange, California, United States
- Palm Springs, California, United States
- Redwood City, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Stanford, California, United States
- Whittier, California, United States
- Aurora, Colorado, United States
+ 91 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Mobile, Alabama, United States; Tucson, Arizona, United States; Carmichael, California, United States; Colton, California, United States; Fontana, California, United States and 105 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.