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Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

ConditionsIntracerebral HemorrhageAtrial Fibrillation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apixaban

    Drug

    Apixaban is an oral anticoagulant of the Factor Xa inhibitor class.

  • Aspirin

    Drug

    Aspirin is an oral antiplatelet drug.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: ApixabanActive comparator 1 intervention
Group B: AspirinPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stroke or death

Incidence of stroke of any type (ischemic or hemorrhagic) or death from any cause

Time frame
Up to 3 years

Secondary outcomes

1

Modified Rankin Scale (mRS) score

Measure of neurologic disability (0=no disability to 6=dead)

Time frame
Change from baseline to 12 months; change over duration of follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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