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

Comparison of the Effect of Device Closure in Alleviating Migraine With Patent Foramen Oval (COMPETE-2)

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 prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.

Study Overview

• Status: Recruiting
• Conditions: Migraine; Patent Foramen Ovale
• Intervention / Treatment: Device: PFO device closure; Drug: Aspirin

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiangbin Pan, MD; Phone Number: 88396666; Email: panxiangbin@fuwaihospital.org
• Study Contact Backup: Name: Fengwen Zhang, MD; Phone Number: 88396666; Email: zhangfengwen08@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital
      • Contact: Xiangbin Pan, MD; Phone Number: 88396666; Email: panxiangbin@fuwaihospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFO closure	Device: PFO device closure; Participants randomized into this group will take PFO device closure.
Sham Comparator: Shame procedure	Drug: Aspirin; Participants randomized into this group will take aspirin 200mg qd for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Treatment safety	Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment Adverse events after medication treatment	From baseline period to 12-month treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Percentage of migraine change	Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.	From baseline period to 12-month treatment period

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2025

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Estimate): January 9, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Headache Disorders, Primary; Headache Disorders; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Migraine Disorders; Foramen Ovale, Patent; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 2022-1748

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No