Status:
COMPLETED
Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects
Lead Sponsor:
Laval University
Collaborating Sponsors:
Sanofi
Bristol-Myers Squibb
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00799045
Start Date
October 1 2008
End Date
December 1 2016
Last Update
February 26 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Laval
Québec, Canada, G1V 4G5