Valvular & structural heart diseaseRandomised controlled trial
Antithrombotic treatment for migraine in patients with patent foramen ovale: multicentre, randomised, active controlled, open label trial
- Randomised controlled trial
- investigator initiated
- multicentre
- active controlled
- open label
- blinded outcome assessment
- hierarchical hypothesis testing
- non-inferiority
- 39 centres in China
Authors' conclusion
The antithrombotic agents evaluated in this trial (aspirin, clopidogrel, and rivaroxaban) were all non-inferior to metoprolol for responder rate in participants with PFO and migraine. Rivaroxaban also showed superior responder rates over metoprolol without an increase in major bleeding events.
Study context
- Population
- Adults aged 18–64 years with migraine >1 year, ≥4 migraine days/month and PFO confirmed by echocardiography984 in full analysis set
- Participants
- 1,000 adults
- Comparison
- Antithrombotic treatment vs metoprolol
- Aspirinn = 240
- Clopidogreln = 235
- Rivaroxabann = 236
- Metoprololn = 233reference
- Primary endpoint
- Proportion achieving ≥50% reduction in monthly migraine days or attacks from baseline
- Follow-up
- Weeks 9-12
Primary result
As reported in the abstract
Responder rate (≥50% reduction in monthly migraine days or attacks)
Absolute difference
16.2 %
98.33% CI 6.0–26.4
P < 0.001
Events by treatment group
Rivaroxaban vs Metoprolol
absolute difference 16.2 % (98.33% CI 6.0–26.4); P < 0.001
Secondary outcomes
Migraine days and attacks, complete migraine cessation, migraine-specific quality of life
- Rivaroxaban associated with greater reductions in migraine days and attacks, higher complete cessation and greater quality-of-life improvement than metoprolol
Safety
Major bleeding
- No major bleeding events occurred
Original publication
Antithrombotic treatment for migraine in patients with patent foramen ovale: multicentre, randomised, active controlled, open label trial. BMJ. Published 29 July 2026. doi:10.1136/bmj-2026-100103
Summarised from the published abstract; every number is checked against it