The purpose of the study is to compare the effects of apixaban (also known as Eliquis®) with aspirin in patients with atrial fibrillation and a recent brain hemorrhage to see which is better in preventing strokes and death.
Subjects will be in the research study for up to 3 years (minimum of 1 year). About 700 people will take part in this study at approximately 125 sites throughout the United States.
This is a research study looking to compare the effects (good and bad) of the ARCADIA study drugs (apixaban and aspirin) on the occurrence of silent strokes and memory loss after stroke.
This add-on study to the ARCADIA trial involves cognitive testing (tests designed to measure subjects memory, thinking, reasoning and understanding) and an MRI scan of their brain.
There will be about 5 study visits over the length of the study (approximately 3 years), or for a long as subjects are in the parent ARCADIA study.
The purpose of this research study is to evaluate the desired outcome and safety of the study drug, tenecteplase, compared to a placebo in patients with an acute ischemic stroke. Tenecteplase is approved by the health authorities for the treatment of heart attack, but it is not approved for stroke.
Participants will be screened within 4.5 to 24 hours after the onset of the stroke and will undergo 2 followup MRIs within 96 hours.
Follow-up clinic visits will occur at 30 and 90 days after study treatment. Total study duration is about 3 months.
ARCADIA is a multicenter, biomarker-driven, randomized, double-blind, active-control, phase 3 clinical trial of apixaban (Eliquis) versus aspirin in patients who have evidence of atrial cardiopathy and a recent stroke of unknown cause. 1100 subjects will be recruited over 2.5 years at 120 sites in the NINDS StrokeNet consortium. Subjects will be followed for a minimum of 1.5 years and a maximum of 4 years for the primary efficacy outcome of recurrent stroke and the primary safety outcomes of symptomatic intracranial hemorrhage and major hemorrhage other than intracranial hemorrhage.