Thrombolysis in Factor Xa-inhibitors Trial
Recruiting
Phase 3
Interventional Study
Stroke
Stroke (in Patients With Atrial Fibrillation)
Ischemic Stroke
Acute Ischemic Stroke
Anticoagulant Therapy
Factor Xa Inhibitor
Intracranial Hemorrhages
Hemorrhagic Transformation Due to Acute Stroke
Bleeding in the Brain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Guri Hagberg · Other
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About This Trial
This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT). IVT is a common emergency treatment for stroke, but current guidelines say it should not be given to people who have taken FXa inhibitors in the last 48 hours. This is because doctors worry that IVT might cause dangerous bleeding in the brain.
However, new…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participant must be 18 years of age or older.
2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)
3. Clinical diagnosis of AIS with disabling neurological deficit
4. Presenting within 4.5 h of symptom …
Contacts