Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

  • Interventional
  • Recruiting
  • NCT03907046
Eligibility Details Visit Clinicaltrials.gov

Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery

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.

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 high-risk non-valvular AF (CHA2DS2-VASc score ≥ 2). 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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

         - CHA2DS2-VASc score ≥ 2

         - 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 MI).

         - 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 therapeutic 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

At a Glance

National Government IDNCT03907046

IRB#CIRB19-1517

Lead SponsorYale University

Lead PhysicianScott Mendelson

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting