Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Brief 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.
Brief Title
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
Detailed 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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
443-615-4729
Central Contact Email
kevin.sheth@yale.edu
Central Contact Role
Contact
Central Contact Phone
646-962-8284
Central Contact Email
hok9010@med.cornell.edu
Completion Date
Completion Date Type
Estimated
Conditions
Intracerebral Hemorrhage
Atrial Fibrillation
Eligibility Criteria
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
Inclusion Criteria
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

Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03907046
Org Class
Other
Org Full Name
Yale University
Org Study Id
2000026409
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Primary Outcomes
Outcome Description
Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause
Outcome Measure
Stroke or death
Outcome Time Frame
Up to 3 years
Secondary Ids
Secondary Id
1U01NS106513-01A1
Secondary Outcomes
Outcome Description
Measure of neurologic disability (0=no disability to 6=dead)
Outcome Time Frame
Change from baseline to 12 months; change over duration of follow-up
Outcome Measure
Modified Rankin Scale (mRS) score
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kathryn Kirchoff
Investigator Email
kkirchof@montefiore.org
Investigator Phone
718-920-6444
Investigator Department
Neurology
Investigator Sponsor Organization
External
Study Department
Neurology
Study Division
Vascular Neurology
Categories Mesh Debug
Heart/Cardiovascular --- ATRIAL FIBRILLATION
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Blood Disorders --- HEMORRHAGE
Heart/Cardiovascular --- ARRHYTHMIAS, CARDIAC
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
MeSH Terms
CEREBRAL HEMORRHAGE
ATRIAL FIBRILLATION
INTRACRANIAL HEMORRHAGES
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
HEMORRHAGE
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
ARRHYTHMIAS, CARDIAC
HEART DISEASES
APIXABAN
ASPIRIN
SALICYLATES
HYDROXYBENZOATES
PHENOLS
BENZENE DERIVATIVES
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
ORGANIC CHEMICALS