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

Primary Purpose

Patent Foramen Ovale, Migraine

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin 100mg
Metoprolol 25 Mg Oral Tablet
Clopidogrel 75mg
Rivaroxaban 20mg
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patent Foramen Ovale focused on measuring Migraine, Patent Foramen Ovale, Medication therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%.

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Migraine Medication Group

Anticoagulation or anti-platelet medication Group 1

Anticoagulation or anti-platelet medication Group 2

Anticoagulation or anti-platelet medication Group 3

Arm Description

Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group.

Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin.

Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel.

Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban.

Outcomes

Primary Outcome Measures

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.
Treatment safety
Adverse events after medication treatment

Secondary Outcome Measures

Migraine days change per month
Change in the mean number of migraine days from baseline to treatment phase.
Number of migraine attacks change per month
Change in the mean number of migraine attacks from baseline to treatment phase.
Percentage of migraine change
Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.

Full Information

First Posted
September 15, 2022
Last Updated
January 9, 2023
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05546320
Brief Title
Comparison of the Effect of Medication Therapy in Alleviating Migraine With Patent Foramen Ovale
Acronym
COMPETE
Official Title
COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale, Migraine
Keywords
Migraine, Patent Foramen Ovale, Medication therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Migraine Medication Group
Arm Type
Active Comparator
Arm Description
Patients randomized into migraine medication group will be given Metoprolol 25mg twice a day as the control group.
Arm Title
Anticoagulation or anti-platelet medication Group 1
Arm Type
Experimental
Arm Description
Patients randomized into anticoagulation or anti-platelet medication group will be given aspirin.
Arm Title
Anticoagulation or anti-platelet medication Group 2
Arm Type
Experimental
Arm Description
Patients randomized into anticoagulation or anti-platelet medication group will be given clopidogrel.
Arm Title
Anticoagulation or anti-platelet medication Group 3
Arm Type
Experimental
Arm Description
Patients randomized into anticoagulation or anti-platelet medication group will be given Rivaroxaban.
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg
Intervention Description
Anticoagulation or anti-platelet or migraine medication therapy will be provided for different groups.
Intervention Type
Drug
Intervention Name(s)
Metoprolol 25 Mg Oral Tablet
Intervention Description
Metoprolol 25mg will be provided for the participants twice a day.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75mg
Intervention Description
Clopidogrel 75mg will be provided for the participant once a day.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 20mg
Intervention Description
Rivaroxaban 20mg will be provided for the participant once a day.
Primary Outcome Measure Information:
Title
Responder rate
Description
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.
Time Frame
From baseline period to 3-month treatment period
Title
Treatment safety
Description
Adverse events after medication treatment
Time Frame
From baseline period to 3-month treatment period
Secondary Outcome Measure Information:
Title
Migraine days change per month
Description
Change in the mean number of migraine days from baseline to treatment phase.
Time Frame
From baseline period to 3-month treatment period
Title
Number of migraine attacks change per month
Description
Change in the mean number of migraine attacks from baseline to treatment phase.
Time Frame
From baseline period to 3-month treatment period
Title
Percentage of migraine change
Description
Participants experienced 75%, or greater reduction in migraine headache attacks during treatment phase as compared to baseline phase.
Time Frame
From baseline period to 3-month treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 ； Diagnosed migraine by ICHD-3 History of migraine longer than 1 year TCD/TTE/TEE diagnosed patent foramen ovale Willing to participant and agree to follow-ups Exclusion Criteria: Migraine caused by other reason Had TIA/stroke history Hypersensitive or hyposensitive to the study drug With a history of anticoagulation or anti-platelet drug intake 3 month before randomization. With a history of metoprolol intake 3 month before randomization, and migraine attacks did not reduced 50%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangbin Pan
Phone
88396666
Email
panxiangbin@fuwaihospital.org
First Name & Middle Initial & Last Name or Official Title & Degree
Fengwen Zhang
Phone
88396666
Email
zhangfengwen08@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangbin Pan, MD
Phone
88396666
Email
panxiangbin@fuwaihospital.org

12. IPD Sharing Statement

Learn more about this trial

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

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