Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04435418
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients
2. Must be ≥ 18 years of age.
3. Diagnosis of ischemic stroke, or Transient Ischemic Attack (TIA, defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of onset). In cases where onset time cannot be established, it will be considered to be the time when patient was last known to be well.
4. CT scan or MRI, with findings consistent with an ischemic etiology of symptoms.
5. Atrial Fibrillation (AF, paroxysmal or persistent), confirmed with ECG/Holter monitor, or by history (clinical documentation of previous AF must be provided).
6. Patients prescribed apixaban by their treating physician following their stroke/TIA.
7. Ability to obtain consent from patient or legally authorized representative.
Exclusion Criteria:
1. Acute or chronic renal failure, defined as eGFR \<30 ml/min (Cockcroft Gault formula).
2. Known hypersensitivity to apixaban.
3. Prior treatment with apixaban or any other novel oral anticoagulant (including all Factor Xa antagonists). Treatment with warfarin prior to the stroke/TIA is acceptable, but enrolment cannot begin until the INR is ≤2.0.
4. Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery.
5. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
6. Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm.
7. Hereditary or acquired haemorrhagic diathesis.
8. Stroke mimics (such as seizures, migraine etc.)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04435418
Study Brief:
Protocol Section:
NCT04435418