A Study to Evaluate Anticoagulation for Stroke Prevention and Recovery After Intracerebral Hemorrhage (ICH)

Overview

About this study

The primary purpose of this study is 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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Age at least 18 years.
  • Intracerebral hemorrhage (ICH) (including primary intraventricular hemorrhage) confirmed by brain CT or MRI.
  • Can be randomized within 14-120 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.
  • Able to comply with all study procedures and available for duration of the study.
  • For females of reproductive potential: use of highly effective contraception.

Exclusion Criteria: 

  • History of ICH before index event.
  • Active infective endocarditis.
  • Lobar ICH with cerebral amyloid angiopathy.
  • 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.
  • Life expectancy < 1 year.
  • 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 participation in the trial.
  • Unwilling to discontinue prohibited medications.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Jason Siegel, M.D.

Open for enrollment

Contact information:

Meredith McDonald B.S.

(904)953-2903

Mcdonald.Meredith@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available