drugset / Trial / NCT05387954
PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years
Phase 3
Recruiting
792 enrolled
Assistance Publique - Hôpitaux de Paris
Abbott · collabCentre Hospitalier St Anne · collabMinistry of Health, France · collabOcclutech International AB · collabW.L.Gore & Associates · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (\> 20 microbubbles) or a PFO associated with an ASA (\> 10 mm), and an otherwise unexplained ischemic stroke.
Timeline
- Start
- 2023-07-07
- Primary completion
- 2031-07-07
- Completion
- 2031-07-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 5 mg | Oral |
| Subject | Aspirin | Small molecule | 75 mg | — |
| Subject | Clopidogrel | Small molecule | 75 mg | — |
| Subject | Dabigatran | Unknown | 150 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 20 mg | Oral |