COMPETE Cohort Study

Migraine Clinical Trial

Official title:

Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval: COMPETE Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033937
• Other study ID #: 2022-1758-2
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xiangbin Pan, MD
• Phone: 88396666
• Email: panxiangbin[@]fuwaihospital.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a multi-center cohort study aiming to find the correlation between PFO closure and migraine attacks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 ;

2. Diagnosed migraine by ICHD-3

3. History of migraine longer than 1 year, and symptoms severely disturbing daily life.

4. TCD/TTE/TEE diagnosed patent foramen ovale with right to left shunt

5. Willing to participant and agree to follow-ups

6. Received at least three different types of migraine preventive drugs, the responder rate of previous therapy did not receive 50%.

Exclusion Criteria:

1. Migraine caused by other reason

2. Had TIA/stroke history

3. With contraindication or hypersensitive to anti-platelet or anticoagulation drugs.

4. With contraindication to PFO occlusion

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Migraine
• Migraine Disorders
• PFO - Patent Foramen Ovale

Intervention

Device:
• PFO occlusion
Patients in PFO occlusion group received PFO closure using devices.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rate	Defined as a 50% reduction from the monthly number of migraine attacks during the baseline phase to the monthly number of migraine attacks during the treatment phase.	From baseline period to 12-month treatment period
Secondary	Migraine days change per month	Change in the mean number of migraine days from baseline to treatment phase.	From baseline period to 12-month treatment period
Secondary	Number of migraine attacks change per month	Change in the mean number of migraine attacks from baseline to treatment phase.	From baseline period to 12-month treatment period
Secondary	Percentage of complete migraine cessation	Participants experienced complete migraine attacks cessation after treatment phase as compared to baseline phase.	From baseline period to 12-month treatment period