Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale (COMPETE)

January 9, 2023 updated by: Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital

COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale

Migraine attack is an episodic disorder that affects approximately 12% of the population. Previous studies have shown that 41-48% of migraineur have a combination of patent foramen ovale (PFO). Clinical observational studies have been linking medication therapies which include anticoagulation and anti-platelet therapy with the effectiveness in improving migraine symptoms and reducing the frequency of attacks in patients combined with a PFO. However, it has been unclear whether the effectiveness of anticoagulation or anti-platelet therapy outweigh the conventional migraine medication therapy, as a result, we designed a multi-center randomized clinical trial aiming to examine the effectiveness of anticoagulation versus anti-platelet versus migraine medication therapy in migraine patients with PFO and provide a clinical guidance for migraineur.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Exclusion Criteria:

  1. Migraine caused by other reason
  2. Had TIA/stroke history
  3. Hypersensitive or hyposensitive to the study drug
  4. With a history of anticoagulation or anti-platelet drug intake 3 month before randomization.
  5. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Migraine Medication Group
Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group.
Drug: Metoprolol 25 Mg Oral Tablet
Metoprolol 25mg will be provided for the participants twice a day.
Experimental: Anticoagulation or anti-platelet medication Group 1
Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin.
Drug: Aspirin 100mg
Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.
Experimental: Anticoagulation or anti-platelet medication Group 2
Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel.
Drug: Clopidogrel 75mg
Clopidogrel 75mg will be provided for the participant once a day.
Experimental: Anticoagulation or anti-platelet medication Group 3
Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban.
Drug: Rivaroxaban 20mg
Rivaroxaban 20mg will be provided for the participant once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder rate
Time Frame: From baseline period to 3-month treatment period
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 3-month treatment period
Treatment safety
Time Frame: From baseline period to 3-month treatment period
Adverse events after medication treatment
From baseline period to 3-month treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine days change per month
Time Frame: From baseline period to 3-month treatment period
Change in the mean number of migraine days from baseline to treatment phase.
From baseline period to 3-month treatment period
Number of migraine attacks change per month
Time Frame: From baseline period to 3-month treatment period
Change in the mean number of migraine attacks from baseline to treatment phase.
From baseline period to 3-month treatment period
Percentage of migraine change
Time Frame: From baseline period to 3-month treatment period
Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.
From baseline period to 3-month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Principal Investigator: Xiangbin Pan, Fuwai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No2022-1758

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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