Plain-English translation of NCT05387954 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial compares three approaches to prevent another stroke in people over 60 who have had an unexplained stroke caused by a patent foramen ovale (PFO)—a small opening between chambers of the heart. You would be randomly assigned to either have a minimally invasive procedure to close the hole, take a direct-acting oral anticoagulant (a type of blood thinner like apixaban, dabigatran, or rivaroxaban), or take an antiplatelet medication (aspirin or clopidogrel). The goal is to find which approach works best for older adults.
Most previous studies tested these treatments only in younger patients, so doctors don't know which option is safest and most effective for people over 60. About one-third of strokes in older adults have no clear cause but are linked to a PFO, making this an important question to answer.
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If you are randomly assigned to heart closure, you will have a minimally invasive procedure to close the PFO, followed by taking two blood-thinning tablets daily for 3 months, then one tablet long-term. If assigned to medication, you will take one of several blood-thinning pills daily—either a direct-acting anticoagulant or —and attend regular follow-up visits to monitor for stroke recurrence and any side effects. The trial aims to enroll 792 participants and will follow everyone for several years to see which approach prevents the most strokes.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
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