Migraine
Conditions
Keywords
Migraine, atrial septal defects, transcatheter, clopidogrel
Brief summary
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
Detailed description
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.
Interventions
DRUGClopidogrel
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.
Sponsors
Sanofi
Bristol-Myers Squibb
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of monthly migraine days per patient within the 3 months following transcatheter ASD closure. | 3 months |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed