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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT06396858
Eligibility Criteria:
Inclusion Criteria:
* Patients with acute ischemic stroke aged ≥18 years old who, regardless of etiology and mechanism, do not have a definitive indication for anticoagulation, and whose symptoms onset has been within the last 14 days;
* Receiving standard therapy for acute management of ischemic stroke;
* For patients treated with fibrinolytics, a minimum period of 24 hours after the infusion of the lytic drug is required for randomization into the study.
Exclusion Criteria:
* Modified Rankin score of 4 or more at randomization;
* Refusal to provide consent;
* Severe renal failure, with glomerular filtration rate (by CKD-EPI) estimated at \<15 mL/min/1.73 m2;
* Severe liver failure (child C);
* Indication for full-dose anticoagulation (for example, venous thromboembolism or atrial fibrillation);
* Previous hemorrhagic stroke or history of intracranial hemorrhage;
* Systemic treatment with a potent CYP 3A4 inhibitor (such as azole antifungals and protease inhibitors), or with a potent 3A4 inducer (such as rifampicin, phenytoin, phenobarbital, or carbamazepine);
* History of inflammatory bowel disease or chronic diarrhea;
* Prolonged treatment (\> 1 month) with immunosuppressants or systemic corticosteroids;
* History of recurrent pneumonia (3 or more hospitalizations in the last 12 months);
* Pregnancy or breastfeeding;
* Any other comorbidity other than stroke and CV disease (e.g., metastatic cancer) that, in the investigator's opinion, has a significant impact on the 12-month survival.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06396858
Study Brief:
Protocol Section:
NCT06396858