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

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: 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 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborators: Bristol-Myers Squibb; Sanofi
• Treatments: Aspirin; Clopidogrel; 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.