Anticoagulation in ICH Survivors for Stroke Prevention and Recovery

Volunteer for research and contribute to discoveries that may improve health care for you, your family, and your community!

a study on Hemorrhagic Stroke Intracranial Hemorrhage Stroke Atrial Fibrillation Heart Conditions

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Latisha K. Sharma, MD (ucla)
Headshot of Latisha K. Sharma
Latisha K. Sharma

Description

Summary

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.

Official Title

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

Details

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 non-valvular AF. 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.

Keywords

Intracerebral Hemorrhage, Atrial Fibrillation, Cerebral Hemorrhage, apixaban, Aspirin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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
  • Provision of signed and dated informed consent form by patient or legally authorized representative
  • For females of reproductive potential: use of highly effective contraception

You CAN'T join if...

  • 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).
  • 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 109/L) that is chronic in the judgment of the investigator
  • Pregnant or breastfeeding
  • Known allergy to aspirin or apixaban
  • Concomitant participation in a competing 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

Locations

  • Ronald Reagan UCLA Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90095 United States
  • UC Irvine Medical Center accepting new patients
    Orange 5379513 California 5332921 92868 United States
  • UC Davis Medical Center accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • San Francisco General Hospital accepting new patients
    San Francisco 5391959 California 5332921 94110 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90048 United States
  • Hoag Hospital Newport Beach withdrawn
    Newport Beach 5376890 California 5332921 92663 United States
  • Kaiser Permanente Los Angeles Medical Center accepting new patients
    Los Angeles 5368361 California 5332921 90027 United States
  • Los Alamitos Medical Center accepting new patients
    Los Alamitos 5368304 California 5332921 90720 United States
  • Huntington Memorial Hospital withdrawn
    Pasadena 5381396 California 5332921 91105 United States
  • St. Jude Medical Center accepting new patients
    Fullerton 5351247 California 5332921 92835 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Yale University
ID
NCT03907046
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 700 study participants
Last Updated