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

Laval University

Status and phase: Completed; Phase 4

Conditions: Migraine

Treatments: Drug: Clopidogrel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00799045

CLOPI_L_03563

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups

Aspirin + clopidogrel

Experimental group

Description:

Aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following ASD closure.

Treatment:

Drug: Clopidogrel

Aspirin

Active Comparator group

Description:

Aspirin (80 mg/day) for 3 months following ASD closure.

Treatment:

Drug: Clopidogrel