Overview
Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects
Status:
Completed
Completed
Trial end date:
2016-12-01
2016-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Laval UniversityCollaborators:
Bristol-Myers SquibbSanofi
Treatments:
AspirinClopidogrel
Polystyrene sulfonic acid
Ticlopidine
Criteria
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.