Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects

Study Overview
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Brief Summary
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The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.

Detailed Description
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The objective is to evaluate the incidence and severity of new-onset migraine headache episodes following transcatheter ASD closure in patients treated with aspirin alone compared to those on aspirin + clopidogrel therapy as antithrombotic treatment after the procedure. This is a prospective, randomized, double blind, multicenter study, including patients with no previous history of migraine attacks who have been diagnosed with an ASD and for whom transcatheter ASD closure has been clinically indicated. Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure. The occurrence and severity of migraine headaches will be evaluated by a neurologist using a structured headache questionnaire at 1 month and 3 months following ASD closure. An additional 6 month and 1 year follow-up evaluation will be exploratory according to local feasibility.

Official Title
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Clopidogrel On Top of Aspirin For the Prevention of New Onset Migraine Headache Occurrence Following Transcatheter Closure of Atrial Septal Defects: A Prospective Randomized Trial (the CANOA Study)

Conditions
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Migraine

Intervention / Treatment
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* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 year old undergoing transcatheter ASD closure with the Amplatzer Septal Occluder device (AGA medical Corp., MN, USA). Female subjects must be post-menopausal, surgically sterile, or using an effective method of birth control. Signed an informed consent document. Exclusion Criteria: Allergy or intolerance to any of the antithrombotic drugs (aspirin, clopidogrel) used in the study. Need for anticoagulation therapy. Use of ASD closure devices other than the Amplatzer Septal Occluder device. History of migraine headaches (based on migraine headache questionnaire). Refusal to sign the informed consent. Pregnancy or breast-feeding or planning to become pregnant during the study. Previous stroke.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin + clopidogrel<br>Aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure. | Drug: Clopidogrel<br>* Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.<br>* Other names: Clopidogrel (Plavix);|
| Active Comparator: Aspirin<br>Aspirin (80 mg/day) for 3 months following ASD closure. | Drug: Clopidogrel<br>* Patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.<br>* Other names: Clopidogrel (Plavix);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of migraine attacks following ASD closure as evaluated by the intensity of migraine episodes and the Migraine Disability Assessment (MIDAS) questionnaire at 3-month follow-up after ASD closure. |  | 3 months | 
| Incidence of bleeding complications at 3-month follow-up. |  | 3 months | 
| Percentage of patients with new-onset migraine attacks. |  | 3 months | 
| Time to first migraine episode. |  | 3 months | 
| Percentage of patients with migraine headaches at 6-month and 1-year follow-up (exploratory only according to local feasibility). |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, atrial septal defects, transcatheter, clopidogrel