萝莉社

Skip to main content
(904) 244-0411

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

  • Status
    Accepting Candidates
  • Age
    18 Years - NA Years
  • Sexes
    All
  • Healthy Volunteers
I'm interested
Share this study

Description

The ASPIRE study is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of apixaban, compared with aspirin, in patients with a recent ICH and non-valvular AF. A total of 700 patients, age 18 years or older, with an ICH 14-180 days before entry will be randomized in a 1:1 ratio to receive apixaban (5 mg tablets twice daily, or 2.5 mg tablets twice daily for patients meeting standard dose-adjustment requirements) or aspirin (81 mg tablet once daily). Participants will be followed for study outcomes for a median of 24 months (minimum 12 months, maximum 36 months).

Details

Protocol number CED000000883

Eligibility

Inclusion Criteria

• Age at least 18 years
• Intracerebral hemorrhage (ICH) 
• Can be randomized within 14-180 days after ICH onset
• Non-valvular atrial fibrillation or atrial flutter)
• Provision of signed and dated informed consent form by patient or legally authorized representative

Exclusion Criteria
• Index event is hemorrhagic transformation of a brain infarction or hemorrhage into a tumor
• Earlier ICH in 12 months preceding index event
• Active infective endocarditis
• Clear indication for anticoagulant drugs

• Known allergy to aspirin or apixaban
• Clinically significant bleeding diathesis


Lead researchers

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.