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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Study acronym: ASPIRE
StatusRecruiting
PhasePhase 3
Started2020-01-28
View on ClinicalTrials.gov ↗

Amendment history

2026-05-07
Study Status, Contacts/Locations v44
Trial sites expanded: 184 → 187 locations
2026-02-09
Study Status, Contacts/Locations v43
Study sites181→184
2025-08-25
Study Status, Contacts/Locations v42
Study sites176→181
2025-06-23
Study Status, Contacts/Locations v41
Study sites170→176
2025-02-24
Study Status, Contacts/Locations v40
Study sites168→170
Show 39 earlier versions
2025-01-02
Study Status, Contacts/Locations v39
Study sites165→168
2024-12-05
Study Status, Contacts/Locations v38
Study sites163→165
2024-10-23
Study Status, Contacts/Locations v37
Study sitesdetails revised at 2 of 163 sites
2024-08-29
Study Status, Contacts/Locations v36
Study sites156→163
2024-03-20
Study Status, Contacts/Locations v35
Primary completion date2024-04→2027-04
Completion date2024-04→2027-04
Study sites154→156
2023-10-26
Study Status, Contacts/Locations v34
Study sites153→154
2023-09-11
Study Status, Contacts/Locations v33
Study sites152→153
2023-08-30
Study Status, Contacts/Locations v32
Study sites141→152
2023-01-03
Study Status, Study Description, Eligibility, Contacts/Locations v31
Study sites135→141
Eligibility criteria-23 characters
[...] rocardiography or a physician-confirmed history of prior AF CHA2DS2-VASc score ≥ 2 Provision of signed and dated informed consent form by patie [...] let drugs (e.g., requires aspirin or clopidogrel for recent MIcoronary stent). Previous or planned left atrial appendage closure Clinica [...] spirin or apixaban Concomitant participation in a competing therapeutic trial Considered by the investigator to have a condition tha [...]
Study description-35 characters
[...] n, compared with aspirin, in patients with a recent ICH and high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). Seven hundred patients will be enrolled over 3.5 years and [...]
2022-07-28
Study Status, Contacts/Locations v30
Study sites127→135
2022-03-31
Study Status, Contacts/Locations v29
Re-verified, no change to tracked fields
2022-02-21
Study Status, Contacts/Locations v28
Study sites124→127
2022-01-19
Study Status, Contacts/Locations v27
Study sites123→124
2022-01-03
Study Status, Contacts/Locations v26
Study sites122→123
2021-12-10
Study Status, Contacts/Locations v25
Study sites118→122
2021-10-19
Study Status, Contacts/Locations v24
Study sites115→118
2021-09-22
Study Status, Contacts/Locations v23
Study sites112→115
2021-09-03
Study Status, Contacts/Locations v22
Study sites107→112
2021-08-02
Study Status, Contacts/Locations v21
Study sites106→107
2021-07-13
Study Status, Contacts/Locations v20
Study sites105→106
2021-07-12
Study Status, Contacts/Locations v19
Study sitescontacts updated at 4 of 105 sites
2021-07-01
Study Status, Contacts/Locations v18
Study sites104→105
2021-06-08
Study Status, Eligibility, Contacts/Locations v17
Study sites103→104
Eligibility criteria+1 characters
[...] r C Anemia (hemoglobin <8 g/dL) or thrombocytopenia (<100 x 10910^9/L) that is chronic in the judgment of the investigator Preg [...]
2021-06-03
Study Status, Eligibility, Contacts/Locations v16
Study sites100→103
Eligibility criteria+8 characters
[...] e) confirmed by brain CT or MRI Can be randomized within 14-120180 days after ICH onset Non-valvular AF (defined as atrial fib [...] onsent form by patient or legally authorized representative Able to comply with all study procedures and available for duration of the study For females of reproductive potential: use of highly effecti [...] of a brain infarction or hemorrhage into a tumor History of earlier ICH beforewithin 12 months preceding index event Active infective endocarditis Lobar ICH with cerebral amyloid angiopathy Clear indication for anticoagulant drugs (e.g., requires ant [...] by the investigator to [...]
2021-04-14
Study Status, Contacts/Locations v15
Study sites98→100
2021-03-25
Study Status, Eligibility, Contacts/Locations v14
Study sites95→98
Eligibility criteria-24 characters
[...] 109/L) that is chronic in the judgment of the investigator Life expectancy <1 year Pregnant or breastfeeding Known allergy to aspirin or apixab [...]
2021-02-05
Study Status, Contacts/Locations v13
Study sites90→95
2021-01-29
Study Status, Eligibility, Contacts/Locations v12
Study sites84→90
Eligibility criteria+91 characters
[...] : use of highly effective contraception Exclusion Criteria: Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor History of ICH before index event Active infective endocardi [...]
2020-11-18
Study Status, Contacts/Locations v11
Study sites82→84
2020-11-05
Study Status, Contacts/Locations v10
Study sites68→82
2020-09-30
Study Status, Contacts/Locations v9
Study sites59→68
2020-08-20
Study Status, Contacts/Locations v8
Study sites38→59
2020-06-25
Study Status, Contacts/Locations v7
Study sites30→38
2020-06-15
Study Status, Contacts/Locations v6
Study sites26→30
2020-06-09
Suspended→Recruiting Study Status, Contacts/Locations v5
Trial statusSuspended→Recruiting
Reason stoppeddue to COVID-19 restrictions→not stated
Study sites1→26
2020-04-02
Not Yet Recruiting→Suspended Study Identification, Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Suspended
Reason stoppednot stated→due to COVID-19 restrictions
Start dateestimated 2020-03→confirmed 2020-01-28
Study sites0→1
Study title+7 characters
Anticoagulation in ICH Survivors for Stroke Prevention and Recovery After ICH
2020-03-03
Study Identification, Study Status, Sponsor/Collaborators v3
Start date2020-02→2020-03
Collaborators+63 characters
National Institute of Neurological Disorders and Stroke (NINDS)
2019-12-16
Study Status v2
Start date2019-11→2020-02
2019-04-09
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+33 characters
[...] for anticoagulant drugs (e.g., requires anticoagulation for DVTdeep vein thrombosis or PEpulmonary embolism) or antiplatelet drugs (e.g., requires aspirin or clopidogr [...]
Secondary endpointsdetails revised at 1 of 1 entry
2019-04-04
Original filing
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.
Trial Details
NCT Number NCT03907046
Lead Sponsor Yale University
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Intracerebral Hemorrhage, Atrial Fibrillation
Enrollment 700 participants
Start Date 2020-01-28
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-08