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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT03961334
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of ischemic stroke
* level ≥200pmol/L within 72 hours from symptom onset
* Age ≥ 18 years
* Signed informed consent
Exclusion Criteria:
* History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization
* Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator's judgment including therapeutical dose of low-molecular-weight heparin or heparin
* Strong likelihood to be treated with prolonged (i.e. more than 30 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.)
* Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. surgery)
* Previous intracranial hemorrhage in the last year
* Evidence of severe cerebral amyloid angiopathy if MRI scan performed
* Chronic kidney disease with creatinin clearance \<30ml/min and or subject who requires haemodialysis or peritoneal dialysis
* Known bleeding diathesis (e.g. active peptic ulcer disease , platelet count \< 100'000/mm3 or haemoglobin \< 9 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)
* Active infective endocarditis
* CT or MRI evidence of cerebral vasculitis
* Known allergy or intolerance to antiplatelets or DOACs
* Female who is pregnant or lactating or has a positive pregnancy test at time of admission
* Current participation in another drug trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03961334
Study Brief:
Protocol Section:
NCT03961334