COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES, FUWAI HOSPITAL · Sep 28, 2022

Keywords

ClinConnect Summary

The COMPETE-2 trial is a research study looking at whether closing a small hole in the heart, known as a patent foramen ovale (PFO), can help reduce migraine headaches. Migraine affects many people, and research has shown that a significant number of those with migraines also have a PFO. While some previous studies have not found clear benefits from closing the PFO, this trial aims to gather more information to see if it can effectively relieve migraine symptoms in individuals who have both conditions.

To participate in this study, individuals need to be between 18 and 65 years old, have a diagnosed migraine for at least a year, and have been diagnosed with a PFO through heart imaging tests. Additionally, they should have tried migraine medications for at least three months without significant improvement. Participants will undergo a procedure to close the PFO and will be closely monitored during the study to track their migraine symptoms. This trial is currently recruiting participants, and it represents an important step in understanding the potential link between PFO closure and migraine relief.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-65 ；
• • 2. Diagnosed migraine by ICHD-3
• • 3. History of migraine longer than 1 year
• • 4. TCD/TTE/TEE diagnosed patent foramen ovale
• • 5. Willing to participant and agree to follow-ups
• • 6. Undertook medication therapy for three months without a responder rate higher or equal to 50%
• Exclusion Criteria:
• • 1. Migraine caused by other reason
• • 2. Had TIA/stroke history
• • 3. Hypersensitive or hyposensitive to the study drug